Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
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Purpose
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving specialized radiation therapy together with chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial studies the side effects and the best dose of specialized radiation therapy giving together with chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Radiation: 3-dimensional conformal radiation therapy Radiation: hypofractionated radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer |
- Maximum-tolerated RT dose fraction [ Designated as safety issue: No ]
- Radiographic response [ Designated as safety issue: No ]
- Metabolic response [ Designated as safety issue: No ]
- Rates of progression: local/regional/distant [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2012 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.
Secondary
- To evaluate the rate of radiographic response to treatment.
- To estimate the rates of progression: local/regional/distant.
- To estimate the progression-free survival.
- To estimate the overall survival.
OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy.
Concurrent therapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4 to 5.5 weeks.
Consolidation therapy: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically or cytologically documented non-small cell lung cancer (NSCLC)
- Stage: IIIA or IIIB NSCLC; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible
- Tumor Site: Thoracic disease without supraclavicular or contralateral hilar involvement
Pleural Effusion: When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative
- Exudative pleural effusions are excluded regardless of cytology
- Patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible
Patients must have measurable disease
- Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- No patients that are known to be pregnant or nursing
- Granulocytes ≥ 1,500/μl
- Platelet count ≥ 100,000/μl
- Bilirubin ≤1.5 times upper limit of normal (ULN)
- AST (SGOT) ≤ 2.0 times ULN
- Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 70 mL/min
- FEV-1 ≥ 1.2 L/sec or 50% predicted
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy for non-small cell lung cancer (NSCLC)
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Hospital | Recruiting |
| Phoeniz, Arizona, United States, 85054 | |
| Contact: Steven E. Schild, MD 507-538-1760 | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | Recruiting |
| La Jolla, California, United States, 92093-0658 | |
| Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer 858-822-5354 cancercto@ucsd.edu | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| United States, New York | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| Principal Investigator: | James J. Urbanic, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01486602 History of Changes |
| Other Study ID Numbers: | CDR0000719011, CALGB-31102 |
| Study First Received: | December 2, 2011 |
| Last Updated: | December 6, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013