Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed

NCT00003235 | Completed Phase 3 DMC

• 2 other identifiers: CDR0000066107E2597
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 6

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. Combining more than one drug with either standard radiation therapy or radiation therapy given at different times may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation therapy given at different times, in treating patients with stage III non-small cell lung cancer that cannot be surgically removed.

Conditions

Lung Cancer

Keywords

squamous cell lung cancer; large cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenocarcinoma of the lung

Interventions

carboplatin DRUG

paclitaxel DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage IIIA or IIIB non-small cell carcinoma of the lung Adenocarcinoma Squamous cell carcinoma Anaplastic large cell carcinoma Stage IIIA patients must not be candidates for resection after neoadjuvant therapy (unresectable T3N1 or T1-3 primary tumors with metastasis limited to the ipsilateral mediastinal and subcarinal lymph nodes) Mediastinotomy or thoracoscopy required for potentially resectable IIIa disease when ipsilateral mediastinal lymph nodes are less than 2 cm Stage IIIB patients must not have significant pleural effusion (seen on CT scan only OR does not reaccumulate after one thoracentesis and is cytologically negative) Metastases to contralateral mediastinal or supraclavicular nodes allowed Measurable or evaluable disease No distant metastasis or significant pleural effusion PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 mg/dL SGOT no greater than 2 times normal No liver disease with significant hepatic insufficiency Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac arrhythmia or end stage congestive heart failure Neurologic: No preexisting clinically significant peripheral neuropathy No organic brain syndrome Other: No history of prior or concurrent malignancy in the past 5 years except: Surgically cured basal cell carcinoma of the skin Carcinoma in situ of the cervix Not pregnant Fertile patients must use effective contraception during and for 2 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic radiotherapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Trinitas Hospital - Jersey Street Campus

Elizabeth, New Jersey, 07201, United States

Location

Overlook Hospital

Summit, New Jersey, 07902-0220, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Belani CP, Wang W, Johnson DH, Wagner H, Schiller J, Veeder M, Mehta M; Eastern Cooperative Oncology Group. Phase III study of the Eastern Cooperative Oncology Group (ECOG 2597): induction chemotherapy followed by either standard thoracic radiotherapy or hyperfractionated accelerated radiotherapy for patients with unresectable stage IIIA and B non-small-cell lung cancer. J Clin Oncol. 2005 Jun 1;23(16):3760-7. doi: 10.1200/JCO.2005.09.108. Epub 2005 Apr 18.

  PMID: 15837967 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Chandra P. Belani, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 14, 2004
• Study Start: June 1, 1998
• Primary Completion: August 1, 2006
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (6)