A Pilot Study on How Radiotherapy given prior to surgery Affects Recovery in Women Having Breast cancer and undergoing removal of the breast with Reconstruction

A pilot study of assessing surgical morbidity of preoperative radiotherapy in women undergoing whole breast reconstruction - SUPER-RT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090444

Enrollment

Registered

2025-07-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Preoperative RT: Radiotherapy will be given in patients planned for mastectomy with immediate autologous breast reconstruction. With the aim to reduce the late effects of radiation on t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age greater than 18 years and up to 65 years 2. Planned for mastectomy and immediate autologous BR 3. Confirmed indication of post mastectomy RT (locally advanced breast cancer, and multicentric and node positive operable breast cancer)

Exclusion criteria

Exclusion criteria: 1. Inability to give informed consent 2. Any systemic therapy related toxicity affecting planning of locoregional therapy 3. Unwilling to comply with assessment schedules 4. Inflammatory breast cancer 5. Pregnancy associated breast cancer

Design outcomes

Primary

Measure	Time frame
Incidence of perioperative morbidity scored by Clavien Dindo.Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Incidence of successful microvascular anastomosis using the internal mammary vessels Timepoint: Intraoperative;Incidence of successful skin pocket preservation during mastectomy Timepoint: Intraoperative;Incidence of Skin necrosis of the mastectomy flap Timepoint: 1 week;Overall rate of surgical complicationsTimepoint: 8 and 12 weeks;Proportion of patients with Pathological complete response (pCR)Timepoint: 2 weeks;Change in breast-related symptomTimepoint: Post RT between 8-12 weeks, 6 and 12 months;Change in patient satisfactionTimepoint: Post RT between 8-12 weeks, 6 and 12 months;Total duration of surgery in minutes.Timepoint: Immediate post surgery;Intraoperative Blood lossTimepoint: Intraoperative;Duration of hospital stayTimepoint: 1 week	—

Measure

Time frame

Incidence of successful microvascular anastomosis using the internal mammary vessels Timepoint: Intraoperative;Incidence of successful skin pocket preservation during mastectomy Timepoint: Intraoperative;Incidence of Skin necrosis of the mastectomy flap Timepoint: 1 week;Overall rate of surgical complicationsTimepoint: 8 and 12 weeks;Proportion of patients with Pathological complete response (pCR)Timepoint: 2 weeks;Change in breast-related symptomTimepoint: Post RT between 8-12 weeks, 6 and 12 months;Change in patient satisfactionTimepoint: Post RT between 8-12 weeks, 6 and 12 months;Total duration of surgery in minutes.Timepoint: Immediate post surgery;Intraoperative Blood lossTimepoint: Intraoperative;Duration of hospital stayTimepoint: 1 week

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Countries

India

Contacts

Public ContactDr Tabassum Wadasadawala

Tata Memorial Hospital, Mumbai

twadasadawala@actrec.gov.in02227405079

Outcome results

None listed

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