Clinical trial · Interventional
Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Phase III Randomized Study of Paclitaxel and Carboplatin or Cisplatin Followed by Radiotherapy With or Without Concurrent Paclitaxel in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
- 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. Drugs such as paclitaxel may make tumor cells more sensitive to radiation therapy. It is not yet known if combination chemotherapy followed by radiation therapy is more effective with or without paclitaxel in treating unresectable stage III non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy followed by radiation therapy with or without paclitaxel in treating patients who have unresectable 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| chemotherapy | Drug | Chemotherapy | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival rate
Secondary outcomes (4)
- measure
- One-year survival rate and mean survival time
- measure
- Objective response rate and local control
- measure
- Tolerability
- measure
- Safety profile, in terms of acute and delayed toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage III non-small cell lung cancer (NSCLC) * Locoregionally advanced unresectable disease * Previously untreated * Measurable disease * No involvement of supraclavicular lymph nodes * No cytologically positive pleural or pericardial effusion * No invasion to the wall of the esophagus or the cardiac ventricle * No bone marrow involvement * No distant metastases PATIENT CHARACTERISTICS: Age: * 18 to 70 Performance status: * WHO 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * WBC greater than 4,000/mm\^3 * Absolute neutrophil count greater than 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin less than upper limit of normal (ULN) * AST and ALT less than 2.5 times ULN * Alkaline phosphatase less than 5 times ULN * No hepatic abnormalities Renal: * Creatinine less than ULN Cardiovascular: * No myocardial infarction within the past 6 months * No cardiac insufficiency * No uncontrolled arrhythmia Pulmonary: * FEV1 greater than 1 L * DLCO at least 30% predicted * No pneumonia * No other non-disease-related pulmonary complications Other: * No more than 10% of total weight loss over the past 6 months * No other disease that would preclude study * No peripheral neuropathy grade 3 or greater * No other prior or concurrent malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No familial, geographic, or psychological condition that would preclude study * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy * No concurrent immunotherapy Chemotherapy: * No prior systemic chemotherapy Endocrine therapy: * No concurrent endocrine therapy Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * See Disease Characteristics * No prior complete resection of tumor * Prior radical surgical resection allowed if local recurrence of disease * No concurrent major surgery Other: * No other concurrent anticancer therapy or investigational agents
References
Publications (0)
Data not yet available