Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Surgical Treatment Of Stage IIIB Non-Small Cell Lung Cancer After Induction-Chemoradiotherapy
NCT00021112CI-TRIAL-00007476terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
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 chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage IIIB 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 (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary stage IIIB non-small cell lung cancer (NSCLC) * T4, any N, M0 or any T, N3, M0 * No N3 disease due to scalene or supraclavicular lymph node involvement * No primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement * No mixed tumor types with small cell lung cancer * At least 1 unidimensionally measurable target lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * No pre-existing pleural or pericardial effusion * No CNS involvement by CT scan or MRI PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm \^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.25 times ULN * Creatinine clearance at least 60 mL/min Cardiovascular: * No clinical evidence of superior vena cava syndrome Pulmonary: * Postoperative FEV1 and KCO greater than 40% predicted * VO2 max greater than 15 mL/min/kg (if postoperative KCO no greater than 40% predicted) Other: * No other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma) * No active uncontrolled infection requiring IV antibiotics * No pre-existing sensory neurotoxicity grade 2 or greater * No psychological, familial, sociological, or geographical condition that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy for NSCLC * No concurrent immunotherapy during induction chemoradiotherapy * Concurrent colony stimulating factors allowed Chemotherapy: * No prior chemotherapy for NSCLC Endocrine therapy: * No concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * No prior surgery for NSCLC Other: * No other concurrent anticancer drugs during induction chemoradiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.