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CompletedPhase 2NCT00057746
Official study title

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

Study summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedProphylactic cranial irradiation, 2.5 Gy fx and Prophylactic cranial irradiation, 2.0 Gy fx

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 25, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?222 U.S. locations

Locations may change over time.

Who runs it?Radiation Therapy Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Radiation: Prophylactic cranial irradiation, 2.5 Gy fx; Radiation: Prophylactic cranial irradiation, 2.0 Gy fx; Radiation: Prophylactic cranial irradiation, 1.5 Gy fx
02
Explore related studies

How this study is categorized

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

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Radiation therapy→
Study topics
Brain metastases→
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 small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
  • Limited stage (I-IIIB)
  • Confined to 1 hemithorax
  • No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
  • Complete response after induction chemotherapy (with or without thoracic radiotherapy)
  • Consolidative chest radiotherapy may be initiated before study
  • No radiographic evidence of any of the following:
  • Brain metastases
  • Normal brain CT scan or MRI less than 1 month before study
  • Ipsilateral lung metastases
  • Malignant pleural effusion
  • Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray PATIENT CHARACTERISTICS: Age
  • Not specified Performance status
  • Zubrod 0-1 Life expectancy
  • Not specified Hematopoietic
  • Absolute granulocyte count at least 1,500/mm\^3
  • Platelet count at least 75,000/mm\^3
  • Hemoglobin at least 10.0 g/dL\^ Hepatic
  • Not specified Renal
  • Not specified Pulmonary
  • See Disease Characteristics Other
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Neurological function class 1 or 2
  • No epilepsy requiring permanent oral medication
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy
  • Not specified Chemotherapy
  • See Disease Characteristics
  • At least 1 week since prior chemotherapy
  • No concurrent chemotherapy Endocrine therapy
  • Not specified Radiotherapy
  • See Disease Characteristics
  • No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
  • Concurrent thoracic radiotherapy allowed Surgery
  • Not specified Other
  • No concurrent antitumor agents

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

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama
  • Arizona Oncology Services FoundationPhoenix, Arizona
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - OsbornScottsdale, Arizona
  • Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona
  • Highlands Oncology Group - SpringdaleSpringdale, Arkansas
  • Auburn Radiation OncologyAuburn, California
  • Radiation Oncology Centers - Cameron ParkCameron Park, California
  • Rebecca and John Moores UCSD Cancer CenterLa Jolla, California
  • CCOP - Bay Area Tumor InstituteOakland, California
  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California
  • Radiation Oncology Center - RosevilleRoseville, California
  • Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 25, 2016. Always confirm current availability with the study team.

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