CompletedPhase 3NCT00003235
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and paclitaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 15, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Eastern Cooperative Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Radiation: radiation therapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey
  • Overlook HospitalSummit, New Jersey
  • Community Medical CenterToms River, New Jersey
  • St. Francis Medical CenterTrenton, New Jersey
  • University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania
  • University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 15, 2023. Always confirm current availability with the study team.

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