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Multicentre registry for post-operative breast cancer patients treated with unconventional radiation dose fractionation

Multicentre ambispective registry of unconventional adjuvant radiotherapy dose fractionation in breast cancer patients treated at various Indian centres (Multicentre Unconventional RT study) - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055829
Enrollment
3000
Registered
2023-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Tata Memorial Centre, Mumbai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients that received adjuvant radiation to the breast / chestwall and/ nodal regions 2. Treated with an unconventional fractionation regimen ( defined as dose fractionation other than 40Gy/15 fractions or 50Gy/25 fractions, delivered as 1 fractional per day and 5 fractions per week 3. Patients whose radiation treatment and planning details are available in the medical records

Exclusion criteria

Exclusion criteria: 1. Patients whose radiotherapy details are unavailable 2. Patients treated with moderate hypofractionation or conventional fractionation or multi-catheter interstitial brachytherapy for accelerated partial breast irradiation

Design outcomes

Primary

MeasureTime frame
Acute & late radiotherapy toxicities at 1, 2 and 5 years as per the RTOG and CTCAE v 5.0Timepoint: Acute toxicity maximum grade at 3 months & late radiotherapy toxicities at 1, 2 and 5 years

Secondary

MeasureTime frame
1. Uptake of Ultrahypofractionated RT at the participating centres among operable breast cancer (OBC) & locally advanced breast cancer (LABC) 2. Dose constraints achieved with the unconventional fractionation regimen and their impact on the radiation induced toxicities. 3. Locoregional control, disease free survival and overall survival at 2 and 5 years post RT 4. Reasons for choosing unconventional RT dose fractionation 5. Cosmetic outcome of the treated breast using the Harvard/RTOG/ NRG Scoring system 6. Compliance to radiation treatment and overall treatment timeTimepoint: Uptake of ultrahypofractionated RT after 2017 till 2025 Disease control & survival at 2 and 5 years since the date of cancer diagnosis

Countries

India

Contacts

Public ContactDr Rima Sanjay Pathak

Tata Memorial Hospital

drrimapathak@gmail.com02224177033

Outcome results

None listed

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