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Primary Radiotherapy And DIEP flAp Reconstruction Trial (PRADA)

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ClinicalTrials.gov Identifier: NCT02771938
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 2, 2022
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: Radiotherapy before surgery Not Applicable

Detailed Description:

Cancer outcomes are equivalent regardless of the order of systemic treatments and surgery with a trend towards improved overall survival in women age <50 years receiving chemotherapy before surgery. Adjuvant post-mastectomy chest wall RT has been shown to have both a local and survival benefit particularly in high risk patients. Accordingly, patients with T3/T4 breast cancer and/or with a significant burden of axillary disease commonly now receive a treatment sequence comprising primary chemotherapy followed by mastectomy and immediate autologous reconstruction, increasingly using abdominal fat (DIEP reconstruction), and finally adjuvant radiotherapy to the affected chest wall +/- supraclavicular fossa.

There are precedents for the use of upfront (neoadjuvant) radiotherapy (NART) followed by complex cancer surgery. For example, in rectal cancer, there is substantial evidence for the use of neoadjuvant chemotherapy and radiotherapy followed by aggressive surgical excision as the standard of care in patients with a threatened or involved circumferential margin. Short-course preoperative radiotherapy has been tested in multiple trials in rectal cancer, including the Swedish Rectal Cancer Trial, Dutch Colorectal Cancer Group Study and more recently the Medical Research Council CR07 trial. All three studies demonstrated better local control and improved disease-free and overall survival. Flap reconstruction of the perineum at the time of abdomino-perineal resection is well described as a method to reduce perineal morbidity and is indicated when primary closure cannot be achieved after wide local resection. By transferring a bulk of vascularized soft tissue into the irradiated pelvis, flap reconstruction has been shown to reduce infection rates, fill pelvic dead space, prevent wound dehiscence, and reduce time to healing. 'Short course' pre-operative rectal radiotherapy: surgery is generally undertaken 7-10 days after completion of radiotherapy with an acceptable impact on post-operative complication rate.

There is one published series of NART in breast cancer reporting an acceptable post-operative complication rate. Following on from this, surgeons and clinical oncologists from Imperial College and the Royal Marsden have begun to develop a limited experience of mastectomy and DIEP reconstruction 2-6 weeks following completion of radiotherapy (10 cases, no significant post-operative complications). This non-randomised phase I study sets out to formally evaluate the safety of reversing the order of mastectomy plus immediate DIEP flap reconstruction and adjuvant radiotherapy, with a view to a subsequent randomised controlled trial testing local control and cosmetic outcomes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary Radiotherapy And DIEP flAp Reconstruction Trial
Actual Study Start Date : January 14, 2016
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Radiotherapy before surgery
Radiotherapy followed by mastectomy and DIEP flap reconstruction
Other: Radiotherapy before surgery
Radiotherapy followed by mastectomy and DIEP flap reconstruction




Primary Outcome Measures :
  1. Number of participants with presence of open breast wound [ Time Frame: 4 weeks after mastectomy and DIEP flap reconstruction ]
    Presence of open breast wound at 4 weeks after mastectomy & DIEP flap reconstruction


Secondary Outcome Measures :
  1. Volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging [ Time Frame: 3 months and 12 months after surgery ]
    Difference in volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging at 3 months and 12 months after surgery.

  2. Patient satisfaction [ Time Frame: 3 months and 12 months after surgery ]
    Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, three months after, and 12 months after surgery.

  3. Applanation tonometry measure of breast compressibility between the reconstructed and non-reconstructed breast [ Time Frame: 3 months and 12 months after surgery ]
    Difference in breast compressibility between the reconstructed and non-reconstructed breast using applanation tonometry at 3 months and 12 months following surgery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771938


Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Fiona MacNeill Royal Marsden NHS Foundation Trust
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02771938    
Other Study ID Numbers: CCR4328
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Royal Marsden NHS Foundation Trust:
radiotherapy, breast cancer, DIEP flap
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases