Trial Outcomes & Findings for Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus (NCT NCT00476086)

NCT ID: NCT00476086

Last Updated: 2018-08-24

Results Overview

Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle
• Results posted on: 2018-08-24

Participant Flow

20 participants were enrolled between May 2007 and August 2011.

Participant milestones

Measure	Oxaliplatin/ Gemcitabine Then Radiation Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Overall Study STARTED	20
Overall Study Received Chemotherapy	19
Overall Study Received Radiation	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Oxaliplatin/ Gemcitabine Then Radiation Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Overall Study Alternative therapy	1
Overall Study Progressive Disease	4

Baseline Characteristics

Oxaliplatin and Gemcitabine Followed by Radiation Therapy in the Management of Mixed Mullerian Tumors of the Uterus

Baseline characteristics by cohort

Measure	Oxaliplatin/ Gemcitabine Then Radiation n=20 Participants Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed. on
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 cycles of chemotherapy which approximates 3 months given the 28-day cycle

Population: The analysis dataset is comprised of all participants who started chemotherapy.

Feasibility in this study was based on the chemotherapy regimen. The chemotherapy completion rate is defined as the percentage of patients who complete 3 cycles of oxaliplatin and gemcitabine chemotherapy prior to radiation therapy.

Outcome measures

Measure	Oxaliplatin/ Gemcitabine Then Radiation n=19 Participants Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Chemotherapy Completion Rate	100 percentage of participants Interval 85.0 to 100.0

SECONDARY outcome

Timeframe: Radiation therapy was within 4-6 weeks of last chemotherapy dose. Participants received up to 5 weeks of radiation therapy.

Population: The analysis dataset is comprised of all participants who started chemotherapy.

Disease was evaluated radiologically at baseline and every X cycles on treatment; Treatment continued if radiological exam showed no progressive disease

Outcome measures

Measure	Oxaliplatin/ Gemcitabine Then Radiation n=19 Participants Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Radiation Therapy Completion Rate	79 percentage of participants Interval 58.0 to 92.0

Adverse Events

Oxaliplatin/ Gemcitabine

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Radiation

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Oxaliplatin/ Gemcitabine n=19 participants at risk Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.	Radiation n=15 participants at risk On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Infections and infestations Infection Gr0-2 neut, colon	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Investigations ALT, SGPT	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Metabolism and nutrition disorders Anorexia	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)

Other adverse events

Measure	Oxaliplatin/ Gemcitabine n=19 participants at risk Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.	Radiation n=15 participants at risk On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Gastrointestinal disorders Abdomen, pain	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	20.0% 3/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Immune system disorders Allergic reaction	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Alopecia	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Investigations ALT, SGPT	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Metabolism and nutrition disorders Anorexia	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	13.3% 2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Psychiatric disorders Anxiety	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Investigations AST, SGOT	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Musculoskeletal and connective tissue disorders Back, pain	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Constipation	42.1% 8/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	20.0% 3/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Constitutional, other	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Metabolism and nutrition disorders Dehydration	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Psychiatric disorders Depression	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Diarrhea w/o prior colostomy	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	73.3% 11/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Nervous system disorders Dizziness	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Dry mouth	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Dyspepsia	15.8% 3/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Dysphagia	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Edema limb	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Musculoskeletal and connective tissue disorders Extremity-limb, pain	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Fatigue	73.7% 14/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	60.0% 9/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Fever w/o neutropenia	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Vascular disorders Flushing	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders GI-other	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Nervous system disorders Head/headache	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Blood and lymphatic system disorders Hemoglobin	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Hemorrhoids	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	20.0% 3/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Vascular disorders Hot flashes	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Hyperpigmentation	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Metabolism and nutrition disorders Hypomagnesemia	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Infections and infestations Infection w/ gr3-4 neut, anal/perianal	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Infections and infestations Infection-other	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Injection site reaction	15.8% 3/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Musculoskeletal and connective tissue disorders Joint, pain	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Investigations Leukocytes	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Musculoskeletal and connective tissue disorders Muscle, pain	15.8% 3/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Nausea	52.6% 10/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	40.0% 6/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Nervous system disorders Neurologic-other	63.2% 12/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	33.3% 5/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Nervous system disorders Neuropathy-sensory	47.4% 9/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Investigations Neutrophils	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	13.3% 2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Pain NOS	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Pain-other	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Investigations Platelets	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Pruritus/itching	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Injury, poisoning and procedural complications Radiation dermatitis	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	33.3% 5/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Rash/desquamation	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	13.3% 2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Rash: acne/acneiform	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Rectum, pain	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
General disorders Rigors/chills	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Skin, pain	5.3% 1/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	13.3% 2/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Skin and subcutaneous tissue disorders Skin-other	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Nervous system disorders Taste disturbance	10.5% 2/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	0.00% 0/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Renal and urinary disorders Urinary frequency/urgency	0.00% 0/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)
Gastrointestinal disorders Vomiting	21.1% 4/19 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)	6.7% 1/15 • Assessed each cycle of chemotherapy and week of radiation therapy from time of first dose and up to day 30 post-treatment. Participants received a median of 3 cycles (1 cycle = 4 weeks) of chemotherapy and 5 weeks of radiation therapy. Maximum grade toxicity by type was first calculated within two subsets reflecting either adverse events with treatment-attribution of possibly, probably or definitely.related to chemotherapy or radiation therapy Serious and Other AEs were defined as grades 3-5 and grades 1-2, respectively, per CTCAEv3. (Evaluation excludes untreated participants.)

Additional Information

Susana M. Campos, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-5269

Email: susanna_campos@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place