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CompletedPhase 1NCT00016315
Official study title

Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in 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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB 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 gemcitabine hydrochloride

Plus 2 other study approaches.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 17, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?19 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
Sponsor
Radiation Therapy Oncology Group
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.

Cancer type
Non-small cell lung cancer (NSCLC)→
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 loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria:
  • Medically inoperable stage IIIA
  • Unresectable stage IIIA or IIIB
  • Measurable disease on three-dimensional planning CT scan
  • No post-resection intrathoracic tumor recurrence
  • No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure
  • No evidence of small cell histology
  • No evidence of hematogenous or distant metastases PATIENT CHARACTERISTICS: Age:
  • Not specified Performance status:
  • Zubrod 0-1 Life expectancy:
  • Not specified Hematopoietic:
  • Platelet count at least 100,000/mm\^3
  • Absolute granulocyte count at least 2,000/mm\^3
  • Hemoglobin at least 8.0 g/dL Hepatic:
  • Bilirubin no greater than 1.5 mg/dL
  • Serum glutamate oxaloacetate transaminase (SGOT) no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal:
  • Creatinine no greater than 1.5 mg/dL Cardiovascular:
  • No myocardial infarction within the past 6 months
  • No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia Pulmonary:
  • Forced expiratory volume (FEV)\_1 greater than 1,000 mL Other:
  • No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
  • No weight loss of more than 10% in 3 months prior to diagnosis
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy:
  • Not specified Chemotherapy:
  • No prior chemotherapy Endocrine therapy:
  • Not specified Radiotherapy:
  • No prior thoracic or neck radiotherapy Surgery:
  • See Disease Characteristics
  • No prior complete or subtotal 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

  • CCOP - Bay Area Tumor InstituteOakland, California
  • University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida
  • Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa
  • Monmouth Medical CenterLong Branch, New Jersey
  • Akron City HospitalAkron, Ohio
  • Cancer Care Center, IncorporatedSalem, Ohio
  • Delaware County Memorial HospitalDrexel Hill, Pennsylvania
  • Dale and Frances Hughes Cancer CenterEast Stroudsburg, Pennsylvania
  • Mercy Hospital of PittsburghPittsburgh, Pennsylvania
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee
  • Cottonwood Hospital Medical CenterMurray, Utah
  • McKay-Dee Hospital CenterOgden, Utah

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 17, 2015. Always confirm current availability with the study team.

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