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extreme short duration radiotherapy in locally advanced breast cancer after mastectomy.

Post-mastectomy Extreme Hypo-fractionated loco regional Radiation Therapy in locally advanced Breast Cancer(EXHYPO-LABC) - EXHYPO-LABC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051955
Enrollment
638
Registered
2023-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: standard arm: patients will receive locoregional radiotherapy to a total dose of 40Gyin 15#s over a period of 3 week Control Intervention1: test arm: patients will receive locoregional

Sponsors

MAHAMANA PANDIT MADAN MOHAN MALAVIYA CANCER CENTERCANCER CENTER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven breast cancer Age more than 18 years Patients having cT4 disease with or without nodes (confirmed clinically or radiologically) Breast cancer patients with cT3 lesion with at least N1 nodes (confirmed clinically or radiologically) Breast cancer patient with any T with N2 and N3 nodes (confirmed clinically or radiologically) Any patient with >cT3 or cN2 node undergoing NACT prior to surgery (confirmed clinically or radiologically) Surgery must be mastectomy with adequate nodal clearance (minimum 10 nodes dissected and examined in histopathology) Willing to give consent

Exclusion criteria

Exclusion criteria: Patient having IMN node at presentation Patient having cT1T2 and N0-N1 disease and cT3N0 disease Patient undergoing BCS Pre-existing known cardiac comorbidity except Hypertension Prior radiotherapy to any other site Patient having bilateral breast cancer Patient who could not complete their planned chemotherapy. Patient who have undergone immediate reconstruction of their breast Patients in whom the dosimetric criteria is not met.

Design outcomes

Primary

MeasureTime frame
Disease free survivalTimepoint: at 5 years

Secondary

MeasureTime frame
Loco regional recurrence Metastasis-free survival Overall survival Acute and late morbidity Quality of Life Timepoint: at 5 years

Countries

India

Contacts

Public ContactLINCOLN PUJARI

MAHAMANA PANDIT MADAN MOHAN MALAVIYA CANCER CENTER

drlincoln.pujari@gmail.com7735661666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026