Resource-sparing Post-mastectomy Radiotherapy in Breast Cancer

NCT01452672 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2011-10-17

No results posted yet for this study

Summary

This study compares two different field set-ups in patients with breast cancer following a breast resection (mastectomy). These two set-ups are as follows: arm a - radiotherapy to the chest-wall only, and arm b - radiotherapy to the chest-wall and the supraclavicular fossa.

Patients in both treatment arms will receive radiotherapy with a shortened fractionation schedule.

Study hypothesis: irradiation of the chest-wall only is not inferior to irradiation of the chest-wall and supraclavicular fossa in terms of loco-regional control, survival and treatment toxicity.

Conditions

Interventions

RADIATION

Radiotherapy

RT 40 Gy in 15 fractions

RADIATION

Irradiation of the chest-wall and supraclavicular fossa

RT 40Gy in 15 fractions

Sponsors & Collaborators

  • International Network for Cancer Treatment and Research

    collaborator OTHER
  • International Atomic Energy Agency

    lead OTHER_GOV

Principal Investigators

  • Eduardo Rosenblatt, MD · International Atomic Energy Agency

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Cuba
  • Egypt
  • Ghana
  • Morocco
  • Nigeria
  • Pakistan
  • Peru
  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452672 on ClinicalTrials.gov