Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
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. PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Radiation: accelerated conformational radiotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC) * Squamous cell carcinoma * Basaloid carcinoma * Adenocarcinoma * Bronchoalveolar carcinoma * Adenosquamous carcinoma * Large cell carcinoma * Large cell neuroendocrine carcinoma * Giant cell carcinoma * Sarcomatoid carcinoma * Non-small cell carcinoma not otherwise specified * Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows) * No metastatic disease or hilar or mediastinal lymphadenopathy * Must have mediastinoscopy\* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan * No positive lymph nodes on mediastinoscopy\* NOTE: \*Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum * Poor surgical risk, as defined by 1 of the following: * High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy * Pulmonary dysfunction indicated by one or more of the following: * FEV\_1 less than 40% of predicted * DLCO less than 50% of predicted * Oxygen dependent * Chronic PaCO\_2 greater than 45 mm Hg * VO\_2 less than 15 mL/kg/min PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * 0-2 Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No weight loss of more than 10% within the past 6 months * No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer Chemotherapy: * No prior chemotherapy for NSCLC Radiotherapy: * No prior chest radiotherapy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida
- Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida
- Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida
- CCOP - Mount Sinai Medical CenterMiami Beach, Florida
- University of Chicago Cancer Research CenterChicago, Illinois
- Fairview University Medical Center - University CampusMinneapolis, Minnesota
- Saint Luke's HospitalChesterfield, Missouri
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health CenterGrand Island, Nebraska
- Great Plains Regional Medical CenterNorth Platte, Nebraska
- UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska
- Veterans Affairs Medical Center - BuffaloBuffalo, New York
- Oswego HospitalOswego, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 14, 2016. Always confirm current availability with the study team.