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CompletedPhase 1NCT00009789
Official study title

Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedaccelerated conformational radiotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 14, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?20 U.S. locations

Locations may change over time.

Who runs it?Alliance for Clinical Trials in Oncology

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Early-stage or resectable→
Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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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