Clinical trial · Interventional
Gemcitabine, Carboplatin or Paclitaxel Plus Radiation Therapy in Treating Patients With Stage IIIA or IIIB Non-Small Cell Lung Cancer
A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
NCT00016315CI-TRIAL-00019806completedPhase 1ClinicalTrials.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: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in 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 radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or 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)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (13)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)
- interventionNames
- Drug: gemcitabine hydrochloride
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm 2
- description
- Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT
- interventionNames
- Drug: gemcitabine hydrochloride
- Drug: paclitaxel
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Arm 3
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria: * Medically inoperable stage IIIA * Unresectable stage IIIA or IIIB * Measurable disease on three-dimensional planning CT scan * No post-resection intrathoracic tumor recurrence * No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure * No evidence of small cell histology * No evidence of hematogenous or distant metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute granulocyte count at least 2,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * Serum glutamate oxaloacetate transaminase (SGOT) no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia Pulmonary: * Forced expiratory volume (FEV)\_1 greater than 1,000 mL Other: * No other invasive malignancy within the past 3 years except nonmelanoma skin cancer * No weight loss of more than 10% in 3 months prior to diagnosis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic or neck radiotherapy Surgery: * See Disease Characteristics * No prior complete or subtotal tumor resection
References
Publications (3)
- RESULTChoy H, Jain AK, Moughan J, Curran W, Whipple G, Demas WF, Ettinger DS. RTOG 0017: a phase I trial of concurrent gemcitabine/carboplatin or gemcitabine/paclitaxel and radiation therapy ("ping-pong trial") followed by adjuvant chemotherapy for patients with favorable prognosis inoperable stage IIIA/B non-small cell lung cancer. J Thorac Oncol. 2009 Jan;4(1):80-6. doi: 10.1097/JTO.0b013e318191503f. PMID 19096311
- RESULTChoy H, Swann S, Curran W, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG 0017 study. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-70, S42, 2005.
- RESULTChoy H, Swann S, Walter C, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG study. [Abstract] J Clin Oncol 23 (Suppl 16): A-7103, 646s, 2005.