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Radiation Therapy Schedules for Breast Cancer

Q: Are there any restrictions for participants in this clinical trial?

<p>350 patients with <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, aged 50 to 90, are eligible for this trial. Key requirements for participants include being clinically N0 or having negative sentinel lymph nodes.</p>

Phase 2

Waitlist Available

Led By Silvia C Formenti, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stage 1 (pT1) breast cancer, excised with negative margins

Clinically N0 or No Regional Lymph node (pN0) or sentinel node negative

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

Study Summary

This trial is testing whether a higher dose of radiation given over a shorter period of time is just as effective as a lower dose given over a longer period of time in treating early stage breast cancer.

Who is the study for?

This trial is for post-menopausal women who have had a segmental mastectomy for Stage 1 breast cancer with negative margins and no lymph node involvement. Candidates must not have had previous radiation to the affected breast or a high proportion of DCIS indicative of EIC in their biopsy.Check my eligibility

What is being tested?

The study compares two radiation treatments for breast cancer: one group receives 600 cGy over five days, while the other gets 800 cGy every other day, completing treatment within a week. Patients will be monitored regularly up to ten years after treatment.See study design

What are the potential side effects?

Potential side effects include skin changes, fatigue, swelling in the treated area (lymphedema), and possible long-term tissue scarring known as fibrosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer was removed with clear margins.

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My cancer has not spread to nearby lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared.

Secondary outcome measures

Recurrence rates will be documented

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 - 800 cGY x 3 fractionsExperimental Treatment1 Intervention

Patients will receive 800 cGY x 3 fractions of radiation therapy every other day for 3 days.

Group II: Arm 1 - 600 cGY x 5 fractionsExperimental Treatment1 Intervention

Patients will receive 600 cGY x 5 fractions of radiation therapy over 5 consecutive days.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,178 Total Patients Enrolled

30 Trials studying Breast Cancer

27,216 Patients Enrolled for Breast Cancer

Silvia C Formenti, M.D.Principal InvestigatorWeill Medical College of Cornell University

1 Previous Clinical Trials

44 Total Patients Enrolled

1 Trials studying Breast Cancer

44 Patients Enrolled for Breast Cancer

Media Library

$Arm 1 600 cGY x 5 fractions Clinical Trial Eligibility Overview. Trial Name: NCT02755896 — Phase 2$

$Breast Cancer Research Study Groups: Arm 1 - 600 cGY x 5 fractions, Arm 2 - 800 cGY x 3 fractions$

$Breast Cancer Clinical Trial 2023: Arm 1 600 cGY x 5 fractions Highlights & Side Effects. Trial Name: NCT02755896 — Phase 2$

$Arm 1 600 cGY x 5 fractions 2023 Treatment Timeline for Medical Study. Trial Name: NCT02755896 — Phase 2$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA sanction this medication?

"While Phase 2 trials don't have the same amount of data to support efficacy, this particular treatment received a safety score of 2."

Answered by AI

Can patients who are 18 or older participate in this research?

"This study is only enrolling patients that are between 50-90 years old."

Answered by AI

Are participants still being recruited for this research?

"Data from clinicaltrials.gov suggests that this trial is no longer searching for patients as it last updated over 2 years ago. Although 4704 other trials are currently underway, this specific study has completed participant recruitment."

Answered by AI

Are there any restrictions for participants in this clinical trial?

"350 patients with cancer, aged 50 to 90, are eligible for this trial. Key requirements for participants include being clinically N0 or having negative sentinel lymph nodes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

2015. "Trial to Compare Radiation Fibrosis With Five Versus Three Fractions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02755896.

All > Fibrosis