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

NCT ID: NCT00043108

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2018-02-28

Brief 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.

Detailed Description

OBJECTIVES:

• 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.
• Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
• Determine the protocol completion rate (CR) of patients treated with this regimen.
• Determine the feasibility and toxicity of this regimen in these patients.
• 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.

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.

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

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)

Group Type: EXPERIMENTAL

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Interventions

carboplatin

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruna J. Turaka, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Mark Hallman, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

P30CA006927

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-G02-2097

Identifier Type: OTHER

Identifier Source: secondary_id

02-014

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000256334

Identifier Type: -

Identifier Source: org_study_id