Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 70	Other	INRC-PITCAP EU-20202, INRC-ITA, NCI-V01-1665, NCT00039039

Objectives

1. Compare the overall survival rate of patients with unresectable stage III non-small cell lung cancer treated with paclitaxel and carboplatin or cisplatin followed by radiotherapy with or without concurrent paclitaxel.
2. Compare the 1-year survival rate and mean survival time in patients treated with these regimens.
3. Compare the objective response rate and local control in patients treated with these regimens.
4. Compare the tolerability of these regimens in these patients.
5. Compare the safety profile and toxicity of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC)
  • Locoregionally advanced unresectable disease
  • Previously untreated



• Measurable disease



• No involvement of supraclavicular lymph nodes



• No cytologically positive pleural or pericardial effusion



• No invasion to the wall of the esophagus or the cardiac ventricle



• No bone marrow involvement



• No distant metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior immunotherapy
• No concurrent immunotherapy

Chemotherapy:

• No prior systemic chemotherapy

Endocrine therapy:

• No concurrent endocrine therapy

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• See Disease Characteristics
• No prior complete resection of tumor
• Prior radical surgical resection allowed if local recurrence of disease
• No concurrent major surgery

Other:

• No other concurrent anticancer therapy or investigational agents

Patient Characteristics:

Age:

• 18 to 70

Performance status:

• WHO 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC greater than 4,000/mm³
• Absolute neutrophil count greater than 2,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin greater than 10 g/dL

Hepatic:

• Bilirubin less than upper limit of normal (ULN)
• AST and ALT less than 2.5 times ULN
• Alkaline phosphatase less than 5 times ULN
• No hepatic abnormalities

Renal:

• Creatinine less than ULN

Cardiovascular:

• No myocardial infarction within the past 6 months
• No cardiac insufficiency
• No uncontrolled arrhythmia

Pulmonary:

• FEV1 greater than 1 L
• DLCO at least 30% predicted
• No pneumonia
• No other non-disease-related pulmonary complications

Other:

• No more than 10% of total weight loss over the past 6 months
• No other disease that would preclude study
• No peripheral neuropathy grade 3 or greater
• No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• No familial, geographic, or psychological condition that would preclude study
• Not pregnant or nursing

Expected Enrollment

A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Outcomes

Overall survival rate

One-year survival rate and mean survival time
Objective response rate and local control
Tolerability
Safety profile, in terms of acute and delayed toxicity

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes or cisplatin IV on day 1. Treatment repeats every 21 days for 2 courses. Patients then proceed to randomized treatment.

• Arm I: Patients receive paclitaxel IV over 1 hour on day 1 and radiotherapy on days 1-5 of each week for 6 weeks.



• Arm II: Patients receive radiotherapy 5 days a week for 7 weeks.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Istituto Nazionale per la Ricerca sul Cancro

Paolo Bruzzi, MD, MPH, PhD, Protocol chair		Ph: 39-010-573-7476 Email: paolo.bruzzi@istge.it

Registry Information
Official Title		Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Trial Start Date		2000-02-01
Registered in ClinicalTrials.gov		NCT00039039
Date Submitted to PDQ		2001-06-22
Information Last Verified		2006-08-15

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