Clinical trial · Interventional
Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Patients With Stage III Non-small Cell Lung Cancer
A Randomized Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, With or Without Thalidomide, in Patients With Stage III Non-Small Cell Lung Cancer (NSCLC)
NCT00004859CI-TRIAL-00014753terminatedPhase 3Results postedClinicalTrials.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): Trial was stopped early for futility
Summary
Brief summary (as posted)
This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of non-small cell lung cancer by stopping blood flow to the tumor. It is not yet known if combination chemotherapy plus radiation therapy is more effective with or without thalidomide.
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 |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A (Paclitaxel + Carboplatin + RT)
- description
- Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly during radiotherapy over one hour. Carboplatin, AUC=2, 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy Radiation therapy started between days 43-50 from day 1 of cycle 1. The primary tumor and areas of known nodal disease received 60 Gy at 2.0 Gy fractions, 5 fractions/week for 30 fractions over 6 weeks to the post chemotherapy tumor volume as seen on computed tomography (CT). The initial 50 Gy was delivered to target volume (TV). The final 10 Gy was delivered to a reduced volume targeting defined by TV
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm B (Paclitaxel + Carboplatin + RT+ Thalidomide)
- description
- paclitaxel, carboplatin, and radiotherapy are same as those in Arm A. thalidomide: Induction chemotherapy dosing, oral daily, starting Day 1 for 24 months or until disease progression. Concurrent chemotherapy / radiotherapy dosing, oral daily, begin with 200 mg thalidomide as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed newly diagnosed non-small cell bronchogenic carcinoma * Squamous cell * Adenocarcinoma * Large cell undifferentiated * Bronchoalveolar * Non-small cell carcinoma not otherwise stated * Unresectable stage IIIA * Mediastinal lymph node enlargement of at least 1 cm but less than 2 cm on computed tomography (CT) scans must have mediastinotomy or thoracoscopy to rule out resectability OR * Stage IIIB disease without significant pleural effusion * Seen on CT scan only (not seen on chest x-ray) or does not reaccumulate after 1 thoracentesis and is cytologically negative * Metastases to contralateral, mediastinal, or supraclavicular nodes allowed * Bidimensionally measurable or evaluable disease * 18 and over * ECOG performance status 0-1 * Adequate hematopoietic, hepatic, and renal function obtained \<=4 weeks prior to registration: * Platelet count at least 100,000/mm\^3 * White Blood Cell (WBC) count at least 4,000/mm\^3 OR absolute neutrophil count at least 2,000/mm\^3 * Bilirubin normal * Serum glutamic oxaloacetic transaminase (SGOT) no greater than 2.5 times upper limit of normal * Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min * Fertile patients must use 2 methods of effective contraception for 4 weeks prior to, during, and for 4 weeks after study therapy * Concurrent filgrastim (G-CSF) allowed for persistent neutropenia Exclusion Criteria: * Positive pregnancy test,pregnant or nursing * Uncontrolled high blood pressure, unstable angina, congestive heart failure, or myocardial infarction within the prior year * Serious cardiac arrhythmias requiring medication * Prior radiotherapy to only area of measurable or active tumor * Less than 5 years since prior chemotherapy * Other active malignancies * Serious uncontrolled active infection * Evidence of greater than grade 1 neuropathy by history or physical examination * History of seizure disorders * Contraindication to daily low-dose (81 mg/day) aspirin
References
Publications (2)
- RESULTBelinsky SA, Grimes MJ, Casas E, Stidley CA, Franklin WA, Bocklage TJ, Johnson DH, Schiller JH. Predicting gene promoter methylation in non-small-cell lung cancer by evaluating sputum and serum. Br J Cancer. 2007 Apr 23;96(8):1278-83. doi: 10.1038/sj.bjc.6603721. Epub 2007 Apr 3. PMID 17406356
- RESULTBelinsky SA, Grimes M, Johnson D, et al.: Predicting gene promoter methylation in lung tumors through examination of sputum and serum. [Abstract] J Clin Oncol 24 (Suppl 18): A-7208, 416s, 2006.