跳至主要内容
临床试验/CTRI/2025/07/090444
CTRI/2025/07/090444尚未招募2 期

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

Tata Memorial Centre2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
20
试验地点
2
主要终点
Incidence of perioperative morbidity scored by Clavien Dindo.

研究概览

简要总结

This study intends to assess preoperative radiotherapy (RT)’s viability and surgical risk in women having mastectomy followed by immediate autologous whole breast reconstruction. Patients with breast cancer who need both a mastectomy and radiation therapy are eligible, as determined by multidisciplinary team decisions. Two to four weeks following the last round of neoadjuvant chemotherapy, preoperative radiotherapy is administered using either IMRT or conventional methods, with treatment volumes encompassing the breast and regional nodes as necessary. To allow for recovery and lower the risk of fibrosis, surgery is planned 4–6 weeks after RT and involves mastectomy and DIEP flap reconstruction. Because of the increased risk of necrosis after preoperative RT, intraoperative use of indocyanine green (ICG) helps evaluate the viability of skin flaps. According to institutional protocols, standard systemic therapies are still being used. Assessments of surgical outcomes, wound healing (using Clavien-Dindo and CDC criteria), patient-reported outcomes (BREAST-Q), cosmetic results, and documentation of complications like flap failure or infection are performed on patients at regular intervals for up to a year. Prior to a planned randomized controlled trial, the study aims to produce preliminary data regarding the safety and feasibility of preoperative RT in this context.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

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

排除标准

  • Inability to give informed consent
  • Any systemic therapy related toxicity affecting planning of locoregional therapy
  • Unwilling to comply with assessment schedules
  • Inflammatory breast cancer
  • Pregnancy associated breast cancer.

结局指标

主要结局

Incidence of perioperative morbidity scored by Clavien Dindo.

时间窗: 12 weeks

次要结局

  • Incidence of successful microvascular anastomosis using the internal mammary vessels
  • Incidence of successful skin pocket preservation during mastectomy
  • Incidence of Skin necrosis of the mastectomy flap
  • Overall rate of surgical complications(8 and 12 weeks)
  • Proportion of patients with Pathological complete response (pCR)(2 weeks)
  • Change in breast-related symptom(Post RT between 8-12 weeks,)
  • Change in patient satisfaction(Post RT between 8-12 weeks,)
  • Total duration of surgery in minutes.(Immediate post surgery)
  • Intraoperative Blood loss(Intraoperative)
  • Duration of hospital stay(1 week)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Tabassum Wadasadawala

Tata Memorial Hospital, Mumbai

研究点 (2)

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