MedTrace Logo

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

NCT02755896 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2025-12-15

No results posted yet for this study

Summary

Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

Conditions

  • Malignant Neoplasm of Breast Stage I

Interventions

RADIATION

Arm 1 600 cGY x 5 fractions

Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days

RADIATION

Arm 2 800 cGY x 3 fractions

Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Silvia C Formenti, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-14
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02755896 on ClinicalTrials.gov