Trial Outcomes & Findings for Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall (NCT NCT00089544)

Last Updated: 2018-04-13

Results Overview

Was to be estimated using a binomial distribution and accompanied by the associated 95% confidence interval. Due to early study closure, this endpoint could not be fully evaluated per the protocol plan.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Duration of treatment (which can continue up to approximately 15 months).

Results posted on

2018-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.	Cohort B (Thalidomide, Radiation, Surgery) Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Overall Study STARTED	16	7
Overall Study COMPLETED	15	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.	Cohort B (Thalidomide, Radiation, Surgery) Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Overall Study Ineligible	1	0

Baseline Characteristics

Preoperative Thalidomide With Radiation Therapy For Patients With Low-Grade Primary Soft Tissue Sarcoma or Thalidomide With Radiation Therapy and Chemotherapy For Patients With High-Grade or Intermediate-Grade Primary Soft Tissue Sarcoma of the Arm, Leg, or Body Wall

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort B (Thalidomide, Radiation, Surgery) n=7 Participants Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.	Total n=22 Participants Total of all reporting groups	Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) n=15 Participants Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
Age, Continuous	47.0 years n=7 Participants	48 years n=5 Participants	49.0 years n=5 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=7 Participants	13 Participants n=5 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Duration of treatment (which can continue up to approximately 15 months).

Population: Eligible patients who started study treatment.

Outcome measures

Outcome measures
Measure	Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) n=15 Participants Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.	Cohort B (Thalidomide, Radiation, Surgery) n=7 Participants Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation Not Compliant	5 participants	2 participants
Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation Compliant	10 participants	5 participants

SECONDARY outcome

Timeframe: From start of treatment to time of surgery

Population: This analysis was not carried out due to the small number of patients accrued to the study. See section "Limitations and Caveats".

Will be estimated using a binomial distribution and accompanied by the associated 95% confidence interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment to time of surgery.

Population: This analysis was not carried out due to the small number of patients accrued to the study. See section "Limitations and Caveats".

Outcome measures

Outcome data not reported

Adverse Events

Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)

Serious events: 9 serious events

Other events: 15 other events

Deaths: 0 deaths

Cohort B (Thalidomide, Radiation, Surgery)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld

Radiation Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) n=15 participants at risk Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.	Cohort B (Thalidomide, Radiation, Surgery) n=7 participants at risk Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Blood and lymphatic system disorders Anemia	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Conjunctivitis	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Nausea	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Vomiting	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Edema limbs	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Fatigue	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Fever	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Gait disturbance	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Infections and infestations - Other	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Skin infection	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Vascular access complication	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	28.6% 2/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Alanine aminotransferase increased	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Alkaline phosphatase increased	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Aspartate aminotransferase increased	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Lymphocyte count decreased	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Neutrophil count decreased	26.7% 4/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Platelet count decreased	20.0% 3/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations Weight loss	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Investigations White blood cell decreased	33.3% 5/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 3/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Nervous system disorders Depressed level of consciousness	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Skin and subcutaneous tissue disorders Rash maculo-papular	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Vascular disorders Hypotension	0.00% 0/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Vascular disorders Thromboembolic event	33.3% 5/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.

Other adverse events
Measure	Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery) n=15 participants at risk Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.	Cohort B (Thalidomide, Radiation, Surgery) n=7 participants at risk Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Blood and lymphatic system disorders Anemia	86.7% 13/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	28.6% 2/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Atrial fibrillation	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Sinus bradycardia	26.7% 4/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Cardiac disorders Sinus tachycardia	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Ear and labyrinth disorders Hearing impaired	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Blurred vision	20.0% 3/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Skin and subcutaneous tissue disorders Alopecia	33.3% 5/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Extraocular muscle paresis	0.00% 0/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Eye disorders Watering eyes	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Anal hemorrhage	0.00% 0/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Constipation	73.3% 11/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	42.9% 3/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Diarrhea	26.7% 4/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dry mouth	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dyspepsia	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Dysphagia	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Gastric ulcer	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Gastrointestinal pain	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Hemorrhoids	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Mucositis oral	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Nausea	86.7% 13/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Oral pain	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Rectal hemorrhage	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Gastrointestinal disorders Vomiting	66.7% 10/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Edema limbs	40.0% 6/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Fatigue	93.3% 14/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	57.1% 4/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Fever	33.3% 5/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Gait disturbance	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Hypothermia	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
General disorders Non-cardiac chest pain	20.0% 3/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Immune system disorders Allergic reaction	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Infections and infestations - Other	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Joint infection	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Soft tissue infection	0.00% 0/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Infections and infestations Urinary tract infection	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	0.00% 0/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Dermatitis radiation	33.3% 5/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	42.9% 3/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	6.7% 1/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	14.3% 1/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.
Injury, poisoning and procedural complications Seroma	13.3% 2/15 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.	28.6% 2/7 Per the protocol, toxicity data was collected via CTCAE3.0 then mapped to CTCAE 4.0 for reporting on this website. Subjects experiencing more than one of a given SAE are counted only once for that SAE. Subjects experiencing more than one of a given "Other (Not Including Serious)" AE are counted only once for that "Other (Not Including Serious)" AE.