Clinical trial · Interventional
Primary Radiotherapy And DIEP flAp Reconstruction Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy before surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy before surgery
- description
- Radiotherapy followed by mastectomy and DIEP flap reconstruction
- interventionNames
- Other: Radiotherapy before surgery
Primary outcomes (1)
- measure
- Number of participants with presence of open breast wound
- timeFrame
- 4 weeks after mastectomy and DIEP flap reconstruction
- description
- Presence of open breast wound at 4 weeks after mastectomy \& DIEP flap reconstruction
Secondary outcomes (3)
- measure
- Volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging
- timeFrame
- 3 months and 12 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDThiruchelvam 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