Primary Radiotherapy And DIEP flAp Reconstruction Trial

NCT02771938 | Completed

• 1 other identifier: CCR4328
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Many women with breast cancer now live for decades after their breast cancer treatment. In view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims to reproduce as natural a breast shape as possible. Keeping a natural breast appearance has been shown to be very important to a woman's emotional and psychological recovery. Breast cancer treatment often includes a combination of surgery, chemotherapy, radiotherapy, anticancer tablets such as Tamoxifen, and newer targeted drugs such as Herceptin. Radiotherapy is usually given after surgery. However, radiotherapy after mastectomy and breast reconstruction can damage the 'new' breast giving a less good breast shape and appearance in the longer term. Also, if recovery is slow following surgery, the radiotherapy is delayed which may reduce its effectiveness. Changing the order of treatments has been shown to be safe and effective for chemotherapy, Herceptin and anticancer tablets but we have very little information on giving radiotherapy before breast cancer surgery. The investigators want to find out if giving radiotherapy before mastectomy and reconstruction alters surgical complication rates and they want to evaluate the appearance of the reconstructed breast when radiotherapy is given before surgery.

Conditions

Breast Cancer

Keywords

radiotherapy, breast cancer, DIEP flap

Outcome Measures

Primary Outcomes (1)

• Number of participants with presence of open breast wound

  Presence of open breast wound at 4 weeks after mastectomy \& DIEP flap reconstruction

  4 weeks after mastectomy and DIEP flap reconstruction

Secondary Outcomes (3)

• Volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging

  3 months and 12 months after surgery

• Patient satisfaction

  3 months and 12 months after surgery

• Applanation tonometry measure of breast compressibility between the reconstructed and non-reconstructed breast

  3 months and 12 months after surgery

Study Arms (1)

Radiotherapy before surgery

EXPERIMENTAL

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Other: Radiotherapy before surgery

Interventions

Radiotherapy before surgery OTHER

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Radiotherapy before surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \>18 years with histopathologically-confirmed breast cancer, who:
• require mastectomy for any reason (e.g. extensive disease, failed conservative management etc.)
• adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy

You may not qualify if:

• Inability to give informed consent
• MDM unable to make recommendation for radiotherapy based on pre-operative histopathological and imaging findings ie mastectomy pathology required for MDM to decide on need/ target volume for post-mastectomy RT
• Severe chemotherapy toxicity affecting treatment planning schedule

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• Thiruchelvam PTR, Leff DR, Godden AR, Cleator S, Wood SH, Kirby AM, Jallali N, Somaiah N, Hunter JE, Henry FP, Micha A, O'Connell RL, Mohammed K, Patani N, Tan MLH, Gujral D, Ross G, James SE, Khan AA, Rusby JE, Hadjiminas DJ, MacNeill FA; PRADA Trial Management Group. Primary radiotherapy and deep inferior epigastric perforator flap reconstruction for patients with breast cancer (PRADA): a multicentre, prospective, non-randomised, feasibility study. Lancet Oncol. 2022 May;23(5):682-690. doi: 10.1016/S1470-2045(22)00145-0. Epub 2022 Apr 7.

  PMID: 35397804 DERIVED

Related Links

• Primary radiotherapy and deep inferior epigastric perforator flap reconstruction for patients with breast cancer (PRADA): a multicentre, prospective, non-randomised, feasibility study

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fiona MacNeill

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 13, 2016
• Study Start: January 14, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-01

Locations

GB (1)