CompletedPhase 1NCT00009789

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

StatusCompleted
PhasePhase 1
U.S. locations20
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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