MedTrace Logo

Late-term Effects of Hypofractionated Chest Wall and Regional Nodal Irradiation in Patients With Breast Cancer

NCT04175821 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1770

Last updated 2019-11-26

No results posted yet for this study

Summary

Survival of breast cancer patients has improved with multimodality treatment. Hypofractionated radiotherapy (RT) is rapidly emerging as one of the options for breast cancer patients after breast conservation surgery (BCS) but data on postmastectomy radiation therapy (PMRT) with hypofractionation is lacking and there is always concern for the late effects of RT especially with regional nodal irradiation (RNI). The potential survival benefits of locoregional radiation needs to be balanced with late-term effects. There is a dearth of data on RNI with hypofractionation. Therefore, reporting late-term effects of radiation in these patients is of utmost importance, especially with hypofractionation. Very few patients were given PMRT or RNI in the START trials, so definitive conclusions about the safety of shorter fractionation RNI cannot be drawn from these studies.1-3 There are also studies from Canada and the US with similar dose fractionations in the PMRT setting with limited number of patients but without RNI.4,5 There is a world-wide need for data on PMRT and especially with RNI for patients with breast cancer with its late-term consequences. Because of this, many radiation oncology societies are hesitant in recommending hypofractionated RNI. It is also an area for potential research in breast cancer radiotherapy. We have published our clinical outcomes with 3 weeks of adjuvant local and RNI with hypofractionation in the past.6-10 In this study, we will report late-term effects of PMRT and RNI with this schedule in patients with stage II and III breast cancer from a single institute from India which is practicing hypofractionation since 1976.

Conditions

  • Late Effects of Hypofractionated Radiotherapy in Breast Cancer

Interventions

RADIATION

Hypofractionated radiotherapy

35Gy/ 15#/3weeks to chest wall and 40Gy/15#/3 weeks to supraclavicular fossa

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Eligibility

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

Timeline & Regulatory

Start
1990-01-01
Primary Completion
2007-12-31
Completion
2019-06-30

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 NCT04175821 on ClinicalTrials.gov