Clinical trial · Interventional
Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- •Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- assess the efficacy of dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy
- timeFrame
- 72 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available