Clinical trial · Interventional
Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting
- 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. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery. PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced 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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Thoracic RT (50.4 Gy/1.8 Gy Fx) Paclitaxel (50mg/m2/weekly X 6) Carboplatin (AUC 2/weekly X 6)
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Toxic Death Rate
- timeFrame
- 5 years
- measure
- Complete Resection Rates
- timeFrame
- 5 years
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC) * Must have involvement of the superior sulcus, chest wall, or mediastinum * Must have at least 1 of the following: * Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1) * Resectable chest wall disease (T3, N0-1) * Marginally resectable T4, N0-1, or NX central NSCLC * N2 patients who are potentially resectable after induction chemoradiotherapy * No evidence of extrathoracic spread to liver, adrenals, brain, or bone * No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% 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 mg/dL * SGOT no greater than 3 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No superior vena cava syndrome * No myocardial infarction within the past 6 months * No active uncontrolled congestive heart failure * No active uncontrolled arrhythmia within the past 6 months Pulmonary * FEV1 at least 800 mL Other * No other active invasive malignancy requiring therapy within the past 2 years * No ongoing need for adjuvant therapy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study entry PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior pelvic or thoracic radiotherapy Surgery * See Disease Characteristics Other * Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable
References
Publications (0)
Data not yet available