Clinical trial · Interventional
2-weeks of Adjuvant Radiotherapy in Patients With Breast Cancer
A Phase II Study of 2-weeks of Adjuvant Whole Breast/Chest Wall and/or Regional Nodal Radiotherapy in Patients With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators at PGIMER have been practicing hypofractionation radiotherapy with a dose of 35Gy/15#/3wks to the chest wall in post mastectomy and 40Gy/16#/3wks in breast conservation in breast cancer patients for the last 4 decades. It is also a routine practice in UK and few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation help the radiation centers worldwide to meet the growing need for radiation in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study the investigators want to reduce the treatment duration from 3 weeks to 2 weeks. The study will include 20 patients with breast cancer post mastectomy or after breast conservative surgery to be treated with a radiotherapy dose of 34Gy in 10 fractions over 2 weeks. Patients will be assessed for acute radiation toxicity weekly during treatment and after one month of completion of treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm treatment with radiation
- description
- Patients with breast cancer will be given adjuvant hypofractionated radiotherapy
- interventionNames
- Radiation: Hypofractionation
Primary outcomes (1)
- measure
- acute skin and subcutaneous toxicity assessed using a RTOG grading system
- timeFrame
- 1 month
- description
- Acute toxicity will be assessed using a RTOG grading system.
Secondary outcomes (1)
- measure
- Cosmetic score analysis using Harvard/NSABP/RTOG Breast Cosmesis Grading Scale
- timeFrame
- Base line, one month and 6 months after completion of radiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * invasive carcinoma of the breast * breast conservation surgery or mastectomy (reconstruction allowed but not with implant. Tissue expanders with distant metal ports are allowed) * axillary staging \&/or dissection * complete microscopic excision of primary tumour * pT1-3 pN0-2 M0 disease * written informed consent * able to comply with follow up N.B. Concurrent trastuzumab and hormone therapy is allowed Exclusion Criteria: * past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or (ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free * contralateral breast cancer, including DCIS, irrespective of date of diagnosis * breast reconstruction using implants * concurrent cytotoxic chemotherapy (sequential neoadjuvant or adjuvant cytotoxic therapy allowed)
References
Publications (1)
- DERIVEDYadav BS, Sharma SC. A Phase 2 Study of 2 Weeks of Adjuvant Whole Breast/Chest Wall and/or Regional Nodal Radiation Therapy for Patients With Breast Cancer. Int J Radiat Oncol Biol Phys. 2018 Mar 15;100(4):874-881. doi: 10.1016/j.ijrobp.2017.12.015. Epub 2017 Dec 16. PMID 29485066