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CompletedPhase 1 / Phase 2NCT00023673
Official study title

Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.

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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 Dec 22, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?41 U.S. locations

Locations may change over time.

Who runs it?Radiation Therapy Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Drug: carboplatin; Drug: paclitaxel; Radiation: three-dimensional conformal radiation therapy
02
Explore related studies

How this study is categorized

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

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→
Treatment approach
Chemotherapy→Radiation therapy→
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 unresectable stage IIIB non-small cell lung cancer
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell carcinoma
  • Non-small cell carcinoma not otherwise specified
  • All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields
  • Measurable disease on 3-dimensional planning CT scan
  • No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma
  • No stage IV or recurrent disease
  • No distant metastases or supraclavicular lymph node involvement
  • No significant atelectasis (i.e., atelectasis of an entire lung)
  • No pleural effusions, pericardial effusions, or superior vena cava syndrome
  • No lung cancer within the past 2 years
  • Ineligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols PATIENT CHARACTERISTICS: Age:
  • Not specified Performance status:
  • Zubrod 0-1 Life expectancy:
  • Not specified Hematopoietic:
  • Granulocyte count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3 Hepatic:
  • Bilirubin less than 1.5 mg/dL
  • Aspartate aminotransferase (AST) less than 2 times upper limit of normal Renal:
  • Creatinine no greater than 2.0 mg/dL Pulmonary:
  • Forced expiratory volume (FEV)\_1 at least 1.0 L Other:
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No weight loss greater than 5% in the past 6 months
  • No other malignancy within the past year except nonmelanoma skin cancer
  • Completed 3D plan with total lung V20 \</= 30% mean esophageal dose \</= 34 Gy and esophageal V55 \</= 30% PRIOR CONCURRENT THERAPY: Biologic therapy:
  • No prior biologic response modifiers for current lung cancer
  • At least 5 years since prior biologic response modifiers Chemotherapy:
  • No prior chemotherapy for current lung cancer
  • At least 5 years since prior chemotherapy Endocrine therapy:
  • Not specified Radiotherapy:
  • See Disease Characteristics
  • No prior radiotherapy to the thorax Surgery:
  • No prior complete tumor resection

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

  • Mobile Infirmary Medical CenterMobile, Alabama
  • Arizona Oncology Services FoundationPhoenix, Arizona
  • Providence Saint Joseph Medical Center - BurbankBurbank, California
  • Providence Holy Cross Cancer CenterMission Hills, California
  • University of California Davis Cancer CenterSacramento, California
  • Bay MedicalPanama City, Florida
  • Northeast Georgia Medical CenterGainesville, Georgia
  • Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois
  • Alexian Brothers Radiation OncologyElk Grove Village, Illinois
  • Good Samaritan Regional Health CenterMount Vernon, Illinois
  • Oncology Center at Saint Margaret Mercy Healthcare CenterHammond, Indiana
  • Cancer Center at Ball Memorial HospitalMuncie, Indiana

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 22, 2017. Always confirm current availability with the study team.

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