Trial Outcomes & Findings for Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer (NCT NCT00611858)

Last Updated: 2019-01-08

Results Overview

Pathological complete response (pCR) rate is the percentage of participants who achieve pCR defined as no evidence of tumor cells in the surgical specimen including the lymph nodes (down-staging to pathological T0, N0 after planned neoadjuvant therapy).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.

Results posted on

2019-01-08

Participant Flow

Participants were enrolled from May 2008 through July 2012.

Participant milestones

Participant milestones
Measure	Cetuximab With Standard 5-FU and Radiation Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation. Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks. 5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy. Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU.
Overall Study STARTED	13
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cetuximab With Standard 5-FU and Radiation Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation. Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks. 5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy. Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Cetuximab, 5-FU and Radiation as Neoadjuvant Therapy for Patients With Locally Advanced Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Cetuximab: Participants first receive cetuximab at the initial dose of 400 mg/m2 intravenously (IV) administered over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Cetuximab is given as single agent during the first 3 weeks on study and then in combination with 5-FU and radiation. Radiation: Radiation therapy given as standard of care is initiated after the 3rd dose of cetuximab with a total dose of 50.4 Gray (Gy) in 28 fractions over approximately 5.5 weeks. 5-FU: Participants receive 5-Fluorouracil (5-FU) continuous infusion through central venous access at 225 mg/m2/day given 7 days a week starting day 1 of radiation (no later than 3 days) and lasting the duration of radiation therapy. Duration of neoadjuvant therapy is estimated to be 9 weeks. Surgery follows at week 13-17. Sigmoidoscopy is performed for biopsy prior to the 1st dose and after 3rd dose of cetuximab before the initiation of radiation and/or 5-FU.
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.

Population: The analysis dataset is comprised of all enrolled patients.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
Pathological Complete Response Rate	30.8 percentage of participants Interval 11.3 to 57.3

SECONDARY outcome

Timeframe: CT scans for surveillance recommended yearly x 3 years from date of surgery with additional scanning at discretion of treating oncologist. Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.

Population: The analysis dataset is comprised of all enrolled patients.

Local recurrence rate is the percentage of participants experiencing recurrence within the pelvis.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
Local Recurrence Rate	0.0 percentage of participants Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: Disease is assessed at the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.

Population: The analysis dataset is comprised of all enrolled patients.

Complete resection rate is the percentage of participants having all gross disease removed by the surgeon at the time of operation.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
Complete Resection Rate	100.0 percentage of participants Interval 79.4 to 100.0

SECONDARY outcome

Population: The analysis dataset is comprised of all enrolled patients.

Distant recurrence rate is the percentage of participants experiencing recurrence outside the pelvis.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
Distant Recurrence Rate	0.0 percentage of participants Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: Disease is assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration.

Population: The analysis dataset is comprised of all enrolled patients.

All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
Incidence of Grade 4 Treatment-Related Toxicity	3 Participants

SECONDARY outcome

Timeframe: Mean follow-up for this study cohort was 4.4 years from study entry, up to 7.9 years.

1-year overall survival is the percentage of participants remaining alive 1 year from study entry.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
1-Year Overall Survival Rate	100.0 percentage of participants Interval 79.4 to 100.0

OTHER_PRE_SPECIFIED outcome

Population: The analysis dataset is comprised of all enrolled patients.

Disease-Free Survival Rate is the percentage of participants remaining alive without disease progression.

Outcome measures

Outcome measures
Measure	Cetuximab With Standard 5-FU and Radiation n=13 Participants Determine the pathological complete response rate of cetuximab with standard 5-FU and radiation as neoadjuvant therapy in patients with stage II/III rectal cancer.
1-Year Disease-Free Survival Rate	100.0 percentage of participants Interval 79.4 to 100.0

Adverse Events

Cetuximab With Standard 5-FU and Radiation

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab With Standard 5-FU and Radiation n=13 participants at risk Patients with stage II/III rectal cancer who have received cetuximab with standard 5-FU and radiation as neoadjuvant therapy.
Gastrointestinal disorders Proctitis	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Rectum, pain	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Immune system disorders Cytokine release syndrome	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Lymphopenia	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Ulceration	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.

Other adverse events

Other adverse events
Measure	Cetuximab With Standard 5-FU and Radiation n=13 participants at risk Patients with stage II/III rectal cancer who have received cetuximab with standard 5-FU and radiation as neoadjuvant therapy.
Metabolism and nutrition disorders Hypokalemia	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Hemoglobin	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Hearing-other	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Constipation	30.8% 4/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea w/o prior colostomy	76.9% 10/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dyspepsia	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Hemorrhoids	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	38.5% 5/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	53.8% 7/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Proctitis	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Oral cavity, hemorrhage	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Rectum, hemorrhage	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Abdomen, pain	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Rectum, pain	30.8% 4/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	61.5% 8/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Fever w/o neutropenia	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Edema limb	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
General disorders Pain NOS	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, middle ear	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, sinus	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Infections and infestations Infection Gr0-2 neut, urinary tract	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Burn	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Chemoradiation dermatitis	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Injury, poisoning and procedural complications Radiation dermatitis	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Leukocytes	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Lymphopenia	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophils	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Platelets	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Weight loss	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations Alkaline phosphatase	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations ALT, SGPT	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Investigations AST, SGOT	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Anorexia	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypoalbuminemia	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Bicarbonate	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypocalcemia	30.8% 4/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperglycemia	61.5% 8/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypomagnesemia	46.2% 6/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hypernatremia	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyponatremia	38.5% 5/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Back, pain	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Muscle, pain	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Taste disturbance	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Dizziness	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Neuropathy CN XII tongue	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Neuropathy-sensory	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Head/headache	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Insomnia	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Anxiety	23.1% 3/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Sweating	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Dry skin	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Nail changes	30.8% 4/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash/desquamation	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	84.6% 11/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Hand-foot reaction	15.4% 2/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Skin-other	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hypertension	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.
Vascular disorders Thrombosis/thrombus/embolism	7.7% 1/13 • Adverse events (AEs) are assessed through the time of surgery which in this study cohort occurred up to 24 weeks from date of registration. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.

Additional Information

Jeffrey Meyerhardt, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-6855

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place