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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery.

PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Paclitaxel

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

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 100,000/mm^3

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

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