CompletedPhase 2NCT00033553

Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer

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. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.

Checked against the public recordLast updated Jul 19, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations74
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Drug: carboplatin; Drug: gemcitabine hydrochloride; 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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Squamous cell carcinoma * Adenocarcinoma, including bronchoalveolar cell carcinoma * Large cell anaplastic carcinoma, including giant and clear cell carcinoma * Inoperable stage IIIA or IIIB disease * No direct invasion of vertebral body * Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field * Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field * No scalene, supraclavicular, or contralateral hilar node involvement * Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field * No exudative, bloody, or cytologically malignant pleural effusion * Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * The following are not considered measurable disease: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions in a previously irradiated field PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 1.5 mg/dL * AST less than 2 times upper limit of normal Renal: * Creatinine clearance 20-130 mL/min for females * Creatinine clearance 20-150 mL/min for males Pulmonary: * FEV1 at least 1.2 L Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy for NSCLC * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics Radiotherapy: * See Disease Characteristics * No prior radiotherapy for NSCLC Surgery: * At least 2 weeks since prior 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

  • Northeast Alabama Regional Medical CenterAnniston, Alabama
  • Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California
  • Naval Medical Center - San DiegoSan Diego, California
  • Veterans Affairs Medical Center - San DiegoSan Diego, California
  • UCSF Comprehensive Cancer CenterSan Francisco, California
  • Veterans Affairs Medical Center - San FranciscoSan Francisco, California
  • CCOP - Christiana Care Health ServicesNewark, Delaware
  • Lombardi Cancer Center at Georgetown University Medical CenterWashington D.C., District of Columbia
  • Walter Reed Army Medical CenterWashington D.C., District of Columbia
  • Veterans Affairs Medical Center - Washington, DCWashington D.C., District of Columbia
  • Broward General Medical CenterFort Lauderdale, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 19, 2016. Always confirm current availability with the study team.

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