CTRI/2017/08/009197RecruitingPhase 2
Assessment of acute toxicities and early local recurrences in Post mastectomy breast cancer patients by Accelerated Hypo Fractionated Radiotherapy, a single arm clinical trial.
Dr Parthasarathy V1 site in 1 country65 target enrollmentStarted: January 2, 2017Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- the incidence of grade II and above acute radiation induced dermatitis
Study Overview
Brief Summary
This is a single arm clinical trial in which patients with breast cancer who have underwent Modified Radical Mastectomy will receive Post Mastectomy Radiotherapy [PMRT] with a dose of 42.5 Gy in 16 fractions over 3 weeks. The acute toxicities will be assessed using RTOG toxicity gradingscale. Late toxicity will be graded according to RTOG/EORTC Late RadiationMorbidity Scoring Schema.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Biopsy proven patients of carcinoma breast who have underwent Modified Radical Mastectomy.
Exclusion Criteria
- •Patient with ischemic heart disease or other cardiac ailments.
- •Previous history or irradiation to chest wall.
- •Presence of metastasis to liver, brain, contralateral breast, contralateral lymph nodes, bones.
- •Patients who have underwent Breast Conservation Surgery.
- •ECOG performance status > 3.
Outcomes
Primary Outcomes
the incidence of grade II and above acute radiation induced dermatitis
Time Frame: from the start of radiation until 3 months post treatment
Secondary Outcomes
- incidence of other radiation induced toxicities(local recurrence of the tumor)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12Breast NeoplasmNCT00194753University of Washington80
Recruiting
Phase 1
Intratumoral TriMix Injections in Early Breast Cancer PatientsBreast Cancer FemaleEarly-stage Breast CancerNCT03788083Universitair Ziekenhuis Brussel36
Terminated
Phase 2
Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast CancerBreast CancerNCT01861054Dompé Farmaceutici S.p.A20
Completed
Phase 1
A PK Study to Assess the Drug-drug Interaction of a BCRP Inhibitor on AdagrasibHealthy AdultsNCT05924152Mirati Therapeutics Inc.16
Recruiting
Not Applicable
A Study of Treatment-Related Toxicities and Quality of Life After Local Therapy in Chinese Breast Cancer PatientsNCT07010939FangYi3,000