Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With 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. 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.
Checked against the public recordLast updated Aug 10, 2018 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
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.