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CompletedPhase 1 / Phase 2NCT00003202
Official study title

Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with 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 studiedcisplatin and gemcitabine hydrochloride

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 Aug 10, 2018 · 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?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Drug: cisplatin; Drug: gemcitabine hydrochloride; 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)→
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 confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types:
  • Squamous cell carcinoma
  • Adenocarcinoma
  • Bronchoalveolar carcinoma
  • Large cell anaplastic carcinoma
  • Non-small cell lung cancer not otherwise specified
  • Tumors may be multifocal if all of disease is believed to be result of direct spread
  • Disease must be fully accessible by radiotherapy ports for the entire prescribed dose
  • No supraclavicular nodes or diffuse pleural involvement
  • No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion
  • Measurable disease required for phase II of this study PATIENT CHARACTERISTICS: Age:
  • Any age Performance status:
  • ECOG 0-2 Life expectancy:
  • At least 1 year Hematopoietic:
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin greater than 10 g/dL Hepatic:
  • Bilirubin no greater than 2.0 mg/dL Renal:
  • BUN no greater than 1.5 times normal
  • Creatinine no greater than 1.5 times normal Pulmonary:
  • FEV1 no greater than 1 liter except if tumor has negatively impacted
  • pulmonary function Other:
  • No other serious medical or psychiatric illness
  • No prior lung cancer except if free of disease for more than 3 years
  • No other prior malignancy except nonmelanoma skin cancer or if free of
  • disease for more than 1 year
  • Not pregnant or nursing
  • Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy:
  • Not specified Chemotherapy:
  • No prior chemotherapy Endocrine therapy:
  • Not specified Radiotherapy:
  • No prior thoracic radiotherapy
  • Concurrent radiotherapy to other anatomic sites allowed 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

  • Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 10, 2018. Always confirm current availability with the study team.

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