Breast CancerPRADANCT02771938
Primary Radiotherapy And DIEP flAp Reconstruction Trial
A study testing Radiotherapy before surgery in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy before surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jan 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy before surgery
- Keywords
- radiotherapy, breast cancer, DIEP flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy before surgeryOther
Radiotherapy followed by mastectomy and DIEP flap reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy before surgery | Experimental | Radiotherapy followed by mastectomy and DIEP flap reconstruction Receives: Other: Radiotherapy before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with presence of open breast wound
Presence of open breast wound at 4 weeks after mastectomy \& DIEP flap reconstruction
Measured: 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
Difference in volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging at 3 months and 12 months after surgery.
Measured: 3 months and 12 months after surgery
Patient satisfaction
Patient satisfaction (as measured using the BREAST-Q reconstruction module) before, three months after, and 12 months after surgery.
Measured: 3 months and 12 months after surgery
Applanation tonometry measure of breast compressibility between the reconstructed and non-reconstructed breast
Difference in breast compressibility between the reconstructed and non-reconstructed breast using applanation tonometry at 3 months and 12 months following surgery.
Measured: 3 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start14 Jan 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Fiona MacNeill, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771938
- Sponsor's protocol ID
- CCR4328
- Acronym
- PRADA
- Status last verified
- Jan 2022
- First submitted
- 11 May 2016
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35397804
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Radiotherapy And DIEP flAp Reconstruction Trial
- ClinicalTrials.gov ID
- NCT02771938
- Acronym / sponsor ID
- PRADA / CCR4328
- Conditions
- Breast Cancer
- Keywords
- radiotherapy, breast cancer, DIEP flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy before surgery | Experimental | Other: Radiotherapy before surgeryRadiotherapy followed by mastectomy and DIEP flap reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy before surgeryRadiotherapy followed by mastectomy and DIEP flap reconstruction | Other | Radiotherapy before surgery |
Primary outcome
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
3 secondary outcomes
Volume and symmetry between the reconstructed and non-reconstructed breast using 3D-surface imaging
Time frame: 3 months and 12 months after surgery
Patient satisfaction
Time frame: 3 months and 12 months after surgery
Applanation tonometry measure of breast compressibility between the reconstructed and non-reconstructed breast
Time frame: 3 months and 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 35397804Thiruchelvam 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.
- Primary radiotherapy and deep inferior epigastric perforator flap reconstruction for patients with breast cancer (PRADA): a multicentre, prospective, non-randomised, feasibility studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona MacNeill principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy before surgery in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with presence of open breast wound (time frame: 4 weeks after mastectomy and DIEP flap reconstruction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.