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

Alternate Title

Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI FCCC-02014 NCI-G02-2097, NCT00043108

Objectives

1. Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
2. Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
3. Determine the protocol completion rate (CR) of patients treated with this regimen.
4. Determine the feasibility and toxicity of this regimen in these patients.
5. Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC)
  • Must have involvement of the superior sulcus, chest wall, or mediastinum



• Must have at least 1 of the following:
  • Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1)
  • Resectable chest wall disease (T3, N0-1)
  • Marginally resectable T4, N0-1, or NX central NSCLC
  • N2 patients who are potentially resectable after induction chemoradiotherapy



• No evidence of extrathoracic spread to liver, adrenals, brain, or bone



• No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• No prior pelvic or thoracic radiotherapy

Surgery

• See Disease Characteristics

Other

• Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 3 times upper limit of normal

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No superior vena cava syndrome
• No myocardial infarction within the past 6 months
• No active uncontrolled congestive heart failure
• No active uncontrolled arrhythmia within the past 6 months

Pulmonary

• FEV1 at least 800 mL

Other

• No other active invasive malignancy requiring therapy within the past 2 years
• No ongoing need for adjuvant therapy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study entry

Expected Enrollment

Approximately 57 patients will be accrued for this study within 4 years.

Outcomes

Maximum tolerated dose

Outline

Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.

Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Corey Langer, MD, Protocol chair		Ph: 215-728-2985; 888-369-2427 Email: cj_langer@fccc.edu

Registry Information
Official Title		Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
Trial Start Date		2002-07-22
Registered in ClinicalTrials.gov		NCT00043108
Date Submitted to PDQ		2002-06-12
Information Last Verified		2007-05-06
NCI Grant/Contract Number		CA06927

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