Clinical trial · Interventional
Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer
NCT00023673CI-TRIAL-00030895completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have 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 |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| three-dimensional conformal radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase I: 75.25 Gy/36 fx + chemotherapy
- description
- Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Radiation: three-dimensional conformal radiation therapy
- type
- EXPERIMENTAL
- label
- Phase I: 74 Gy/37 fx + chemotherapy
- description
- Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Non-small cell carcinoma not otherwise specified * All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields * Measurable disease on 3-dimensional planning CT scan * No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma * No stage IV or recurrent disease * No distant metastases or supraclavicular lymph node involvement * No significant atelectasis (i.e., atelectasis of an entire lung) * No pleural effusions, pericardial effusions, or superior vena cava syndrome * No lung cancer within the past 2 years * Ineligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Aspartate aminotransferase (AST) less than 2 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Pulmonary: * Forced expiratory volume (FEV)\_1 at least 1.0 L Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No weight loss greater than 5% in the past 6 months * No other malignancy within the past year except nonmelanoma skin cancer * Completed 3D plan with total lung V20 \</= 30% mean esophageal dose \</= 34 Gy and esophageal V55 \</= 30% PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic response modifiers for current lung cancer * At least 5 years since prior biologic response modifiers Chemotherapy: * No prior chemotherapy for current lung cancer * At least 5 years since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * No prior radiotherapy to the thorax Surgery: * No prior complete tumor resection
References
Publications (3)
- RESULTBradley JD, Bae K, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. Primary analysis of the phase II component of a phase I/II dose intensification study using three-dimensional conformal radiation therapy and concurrent chemotherapy for patients with inoperable non-small-cell lung cancer: RTOG 0117. J Clin Oncol. 2010 May 10;28(14):2475-80. doi: 10.1200/JCO.2009.27.1205. Epub 2010 Apr 5. PMID 20368547
- RESULTBradley JD, Moughan J, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. A phase I/II radiation dose escalation study with concurrent chemotherapy for patients with inoperable stages I to III non-small-cell lung cancer: phase I results of RTOG 0117. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):367-72. doi: 10.1016/j.ijrobp.2009.04.029. PMID 20457350
- RESULTBradley JD, Graham M, Suzanne S, et al.: Phase I results of RTOG L-0117: a phase I/II dose intensification study using 3DCRT and concurrent chemotherapy for patients with inoperable NSCLC. [Abstract] J Clin Oncol 23 (Suppl 16): A-7063, 636s, 2005.