Trial Outcomes & Findings for Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer (NCT NCT00004859)

NCT ID: NCT00004859

Last Updated: 2014-06-02

Results Overview

Survival time is defined as time from study entry to death from any cause

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 589 participants
• Primary outcome timeframe: every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5
• Results posted on: 2014-06-02

Participant Flow

The study was activated on January 27, 2000, and was terminated on October 26, 2006. 589 patients were enrolled to the study.

Participant milestones

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
Overall Study STARTED	295	294
Overall Study Eligible	275	271
Overall Study Treated	289	289
Overall Study Treated and Having Toxicity Data	289	288
Overall Study COMPLETED	177	12
Overall Study NOT COMPLETED	118	282

Reasons for withdrawal

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
Overall Study Lack of Efficacy	43	113
Overall Study Adverse Event	31	93
Overall Study Death	5	5
Overall Study Withdrawal by Subject	7	33
Overall Study Protocol Violation	2	2
Overall Study other disease	0	3
Overall Study error	3	1
Overall Study missing data	14	11
Overall Study Other	13	21

Baseline Characteristics

Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) n=275 Participants Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) n=271 Participants Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.	Total n=546 Participants Total of all reporting groups
Age, Continuous	62.9 years STANDARD_DEVIATION 9.0 • n=5 Participants	62.2 years STANDARD_DEVIATION 10.5 • n=7 Participants	62.6 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants	108 Participants n=7 Participants	212 Participants n=5 Participants
Sex: Female, Male Male	171 Participants n=5 Participants	163 Participants n=7 Participants	334 Participants n=5 Participants

PRIMARY outcome

Timeframe: every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5

Population: intent to treat analysis in the 546 eligible patients

Survival time is defined as time from study entry to death from any cause

Outcome measures

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) n=275 Participants active comparator	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) n=271 Participants experimental arm
Overall Survival Time	15.3 Months Interval 12.4 to 20.6	16.0 Months Interval 14.5 to 18.5

SECONDARY outcome

Timeframe: every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year

Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Outcome measures

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) n=275 Participants active comparator	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) n=271 Participants experimental arm
Time to Disease Progression	7.4 Months Interval 6.6 to 8.6	7.8 Months Interval 6.9 to 8.8

SECONDARY outcome

Timeframe: every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year

Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.

Outcome measures

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) n=275 Participants active comparator	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) n=271 Participants experimental arm
Response Rate at Best Response to Treatment	0.35 Proportion of participants Interval 0.29 to 0.41	0.38 Proportion of participants Interval 0.32 to 0.44

Adverse Events

Arm A (Paclitaxel + Carboplatin + Radiation )

Serious events: 222 serious events

Other events: 283 other events

Deaths: 0 deaths

Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)

Serious events: 249 serious events

Other events: 284 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) n=289 participants at risk Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) n=288 participants at risk Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
Immune system disorders Allergic reaction	5.5% 16/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.5% 13/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Ear and labyrinth disorders Inner ear/hearing imparied	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Ear and labyrinth disorders Hearing-other	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Blood and lymphatic system disorders Anemia	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.4% 4/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Leukopenia	23.9% 69/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	28.1% 81/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Lymphopenia	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Neutropenia	50.5% 146/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	55.9% 161/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Thrombocytopenia	3.5% 10/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.1% 6/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Blood and lymphatic system disorders Transfusion: platelets	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Blood and lymphatic system disorders Transfusion:pRBCs	5.2% 15/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.1% 6/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Sinus bradycardia	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Sinus tachycardia	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Supraventricular arrhythmias	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.1% 6/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Vasovagal episode	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Ventricular function	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Edema	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.8% 8/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Hypertension	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Hypotension	1.0% 3/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.8% 8/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Pericardial effusion/pericarditis	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Peripheral arterial ischemia	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Thrombosis/Embolism	2.1% 6/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	10.4% 30/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Visceral arterial ischemia	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Cardiac-other	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Fatigue	5.5% 16/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	14.6% 42/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Fever	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Weight gain	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Weight loss	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.7% 5/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Elevated Partial Thromboplastin Time (PTT)	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Elevated Prothrombin Time (PT)	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Injection site reaction	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Pruritus	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.4% 4/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Radiation dermatitis	1.0% 3/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Rash/desquamation	1.4% 4/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	6.9% 20/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Urticaria	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Wound -infectious	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Wound -non infectious	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Anorexia	3.5% 10/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.2% 12/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Constipation	1.4% 4/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	9.0% 26/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Dehydration	3.5% 10/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.1% 6/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Dyspepsia	1.0% 3/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Dysphagia	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Dysphagia-esophageal radiation	1.4% 4/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.0% 3/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Fistula-intestinal	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Ileus	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Mucositis due to radiation	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Nausea	5.9% 17/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.9% 14/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Stomatitis	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.4% 7/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Taste disturbance	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Vomiting	4.8% 14/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.4% 7/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Diarrhea w/o prior colostomy	1.7% 5/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.8% 8/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders GI-other	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Melena/GI bleeding	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Bilirubin increased	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations AST increased	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations ALT increased	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Blood and lymphatic system disorders Febrile neutropenia	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.4% 7/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Infections and infestations Infection w/ grade 3 or 4 neutropenia	3.1% 9/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	5.2% 15/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Infections and infestations Infection w/ unknown ANC	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.0% 3/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Infections and infestations Infection w/o neutropenia	1.7% 5/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.7% 5/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hyperglycemia	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.4% 4/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hyperkalemia	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hypokalemia	1.0% 3/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	3.8% 11/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hyponatremia	4.8% 14/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	5.2% 15/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Muscle weakness	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.0% 3/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Joint,muscle, bone-other	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Cerebrovascular Ischemia	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Cognitive disturbance	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Confusion	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Depressed level of consciousness	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	5.2% 15/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Dizziness/lightheadedness	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.9% 14/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Hallucinations	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Insomnia	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Memory loss	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Depression	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.0% 3/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Neuropathy-motor	1.7% 5/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	3.1% 9/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Neuropathy-sensory	5.5% 16/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	11.5% 33/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Seizure	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Syncope	1.4% 4/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	2.4% 7/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Tremor	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.7% 5/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Ear and labyrinth disorders Vertigo	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Eye disorders Ocular-other	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Abonominal pain	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.9% 14/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.0% 3/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Cardiac disorders Chest pain	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Ear and labyrinth disorders Earache	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Myalgia	2.4% 7/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.9% 14/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Neuropathic pain	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Pain due to radiation	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.69% 2/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Pain-other	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Apnea	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.4% 4/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.6% 19/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	13.5% 39/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Hiccoughs	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	3.1% 9/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.69% 2/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	1.0% 3/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.2% 12/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.0% 3/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary - other	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Creatinine increased	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Renal and urinary disorders Renal failure	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Reproductive system and breast disorders Erectile impotence	0.35% 1/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.00% 0/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Reproductive system and breast disorders Irregular menses	0.00% 0/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	0.35% 1/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.

Other adverse events

Measure	Arm A (Paclitaxel + Carboplatin + Radiation ) n=289 participants at risk Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.	Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide) n=288 participants at risk Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily. Paclitaxel, carboplatin and radiation same as active comparator.
Investigations Leukopenia	77.2% 223/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	79.5% 229/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Blood and lymphatic system disorders Anemia	82.4% 238/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	82.6% 238/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Neutropenia	64.7% 187/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	76.4% 220/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Thrombocytopenia	37.7% 109/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	37.5% 108/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Edema	8.3% 24/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	28.8% 83/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Vascular disorders Hypotension	6.2% 18/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	10.8% 31/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Fatigue	72.0% 208/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	77.4% 223/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Fever	6.9% 20/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	5.2% 15/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Weight gain	1.4% 4/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	5.9% 17/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Weight loss	27.3% 79/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	22.2% 64/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Alopecia	61.9% 179/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	61.1% 176/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Dry skin	2.4% 7/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	8.7% 25/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Pruritus	7.3% 21/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	6.2% 18/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Injury, poisoning and procedural complications Radiation dermatitis	20.1% 58/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	19.1% 55/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Skin and subcutaneous tissue disorders Rash/desquamation	17.0% 49/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	30.9% 89/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Anorexia	38.1% 110/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	33.7% 97/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Constipation	29.4% 85/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	62.2% 179/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Dehydration	5.2% 15/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	7.3% 21/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Dyspepsia	7.6% 22/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	8.7% 25/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Dysphagia	8.7% 25/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	10.4% 30/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Nausea	48.4% 140/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	45.1% 130/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Stomatitis	20.1% 58/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	23.6% 68/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Taste disturbance	16.3% 47/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	18.8% 54/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Vomiting	23.5% 68/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	17.4% 50/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Gastrointestinal disorders Diarrhea w/o prior colostomy	21.5% 62/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	13.9% 40/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Alkaline phosphatase increased	21.5% 62/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	19.4% 56/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations AST increased	11.8% 34/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	6.6% 19/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Infections and infestations Infection w/o neutropenia	9.3% 27/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	9.7% 28/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hyperkalemia	6.9% 20/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	10.1% 29/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hypokalemia	11.8% 34/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	15.6% 45/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Metabolism and nutrition disorders Hyponatremia	31.5% 91/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	32.6% 94/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Depressed level of consciousness	1.4% 4/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	25.3% 73/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Dizziness/lightheadedness	6.9% 20/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	27.8% 80/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Insomnia	6.2% 18/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.2% 12/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Anxiety/agitation	5.2% 15/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	5.6% 16/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Psychiatric disorders Depression	2.8% 8/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	6.2% 18/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Neuropathy-motor	11.8% 34/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	20.8% 60/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Neuropathy-sensory	55.7% 161/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	71.5% 206/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Tremor	1.0% 3/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	10.8% 31/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Arthralgia	25.6% 74/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	32.3% 93/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Nervous system disorders Headache	9.7% 28/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	12.2% 35/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Musculoskeletal and connective tissue disorders Myalgia	38.1% 110/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	40.6% 117/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
General disorders Pain-other	5.9% 17/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	4.9% 14/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	17.6% 51/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	18.4% 53/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.5% 65/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	34.4% 99/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	7.3% 21/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	8.7% 25/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.
Investigations Creatinine increased	9.3% 27/289 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.	11.1% 32/288 • Toxicity assessment was conducted weekly during chemotherapy,every other month for 24 months during follow up, every 6 months once >24 months from study entry to 5 years.

Additional Information

Study Statistician

Eastern Cooperative Oncology Group (ECOG) Statistical Office

Phone: 617-632-3012

Results disclosure agreements

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

Restriction type: LTE60