CompletedPhase 3NCT00003387
Official study title

Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

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. It is not yet known whether giving chemotherapy before combined chemotherapy and radiation therapy is more effective than combined chemotherapy and radiation therapy alone in treating patients with non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcarboplatin and chemotherapy

Plus 2 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 Jul 20, 2016 · 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?47 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: carboplatin; Drug: chemotherapy; 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 or cytologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Inoperable or unresectable stage IIIA or IIIB disease of the following stage groupings: T1 N2 M0 or T2 N2 M0 T3 N2 M0 and T4 N0-2 M0 eligible if staging is based on closeness to the carina or invasion of the mediastinum or chest wall Patients with contralateral mediastinal disease (N3) or tumors adjacent to but not invading a vertebral body are eligible if all gross disease can be encompassed in the study radiation boost field Patients with a transudate, cytologically negative, nonbloody pleural effusion are eligible if the tumor can be encompassed within a reasonable field of radiotherapy Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALBG 0-1 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 2 times upper limit of normal Renal: Creatinine clearance at least 20 mL/min Other: Not pregnant or nursing Effective contraception required of fertile patients No active second malignancy except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormones except for steroids administered for adrenal failure or septic shock, or hormones administered for non-disease-related conditions (e.g., insulin for diabetes) Glucocorticosteroids permitted as antiemetics Radiotherapy: No prior radiotherapy Surgery: At least 2 weeks since exploratory thoracotomy

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

  • Veterans Affairs Medical Center - BirminghamBirmingham, Alabama
  • University of California San Diego Cancer CenterLa Jolla, California
  • Veterans Affairs Medical Center - San FranciscoSan Francisco, California
  • UCSF Cancer Center and Cancer Research InstituteSan Francisco, California
  • CCOP - Christiana Care Health ServicesWilmington, Delaware
  • Howard University Cancer CenterWashington D.C., District of Columbia
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • CCOP - Mount Sinai Medical CenterMiami Beach, Florida
  • University of Illinois at Chicago Health Sciences CenterChicago, Illinois
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois
  • University of Chicago Cancer Research CenterChicago, Illinois
  • Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 20, 2016. Always confirm current availability with the study team.

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