Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients
NCT ID: NCT03743324
Last Updated: 2018-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
1344 participants
OBSERVATIONAL
2019-01-01
2023-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Radiation in Locally Advanced Breast Cancer
NCT05479409
Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction
NCT07084519
Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
NCT02617043
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
NCT04025164
Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery
NCT04789889
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BR group
Breast reconstruction without radiation therapy
Immediate Breast reconstruction
Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Delayed Breast Reconstruction
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Immediate BR +post-op radiation
Immediate breast reconstruction followed by surgical site radiation therapy
Immediate Breast reconstruction
Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
Radiation +delayed BR
previous post-mastectomy radiation followed by delayed breast reconstruction
Delayed Breast Reconstruction
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immediate Breast reconstruction
Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Delayed Breast Reconstruction
Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
Radiation
Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Karnofsky Performance Status (KPS) larger than 70
* Underwent autologous or prosthetic based breast reconstruction
* No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
Exclusion Criteria
* Local recurrence after mastectomy
* Prior radiation history to chest wall due to other tumors
* Radiation performed more than 6 months after mastectomy
* Interruption of radiation more than 2 weeks
* Gravida or during lactation
* Concurrently undergoing psychotic disorders
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jian Yin
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Schaverien MV, Macmillan RD, McCulley SJ. Is immediate autologous breast reconstruction with postoperative radiotherapy good practice?: a systematic review of the literature. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1637-51. doi: 10.1016/j.bjps.2013.06.059. Epub 2013 Jul 22.
Berbers J, van Baardwijk A, Houben R, Heuts E, Smidt M, Keymeulen K, Bessems M, Tuinder S, Boersma LJ. 'Reconstruction: before or after postmastectomy radiotherapy?' A systematic review of the literature. Eur J Cancer. 2014 Nov;50(16):2752-62. doi: 10.1016/j.ejca.2014.07.023. Epub 2014 Aug 26.
Barry M, Kell MR. Radiotherapy and breast reconstruction: a meta-analysis. Breast Cancer Res Treat. 2011 May;127(1):15-22. doi: 10.1007/s10549-011-1401-x. Epub 2011 Feb 20.
Kelley BP, Ahmed R, Kidwell KM, Kozlow JH, Chung KC, Momoh AO. A systematic review of morbidity associated with autologous breast reconstruction before and after exposure to radiotherapy: are current practices ideal? Ann Surg Oncol. 2014 May;21(5):1732-8. doi: 10.1245/s10434-014-3494-z. Epub 2014 Jan 29.
Losken A, Nicholas CS, Pinell XA, Carlson GW. Outcomes evaluation following bilateral breast reconstruction using latissimus dorsi myocutaneous flaps. Ann Plast Surg. 2010 Jul;65(1):17-22. doi: 10.1097/SAP.0b013e3181bda349.
Selber JC, Kurichi JE, Vega SJ, Sonnad SS, Serletti JM. Risk factors and complications in free TRAM flap breast reconstruction. Ann Plast Surg. 2006 May;56(5):492-7. doi: 10.1097/01.sap.0000210180.72721.4a.
Chang EI, Liu TS, Festekjian JH, Da Lio AL, Crisera CA. Effects of radiation therapy for breast cancer based on type of free flap reconstruction. Plast Reconstr Surg. 2013 Jan;131(1):1e-8e. doi: 10.1097/PRS.0b013e3182729d33.
Kronowitz SJ. Current status of implant-based breast reconstruction in patients receiving postmastectomy radiation therapy. Plast Reconstr Surg. 2012 Oct;130(4):513e-523e. doi: 10.1097/PRS.0b013e318262f059.
Pestana IA, Campbell DC, Bharti G, Thompson JT. Factors affecting complications in radiated breast reconstruction. Ann Plast Surg. 2013 May;70(5):542-5. doi: 10.1097/SAP.0b013e31827eacff.
Chatterjee JS, Lee A, Anderson W, Baker L, Stevenson JH, Dewar JA, Thompson AM. Effect of postoperative radiotherapy on autologous deep inferior epigastric perforator flap volume after immediate breast reconstruction. Br J Surg. 2009 Oct;96(10):1135-40. doi: 10.1002/bjs.6693.
Rogers NE, Allen RJ. Radiation effects on breast reconstruction with the deep inferior epigastric perforator flap. Plast Reconstr Surg. 2002 May;109(6):1919-24; discussion 1925-6. doi: 10.1097/00006534-200205000-00022.
Yueh JH, Slavin SA, Adesiyun T, Nyame TT, Gautam S, Morris DJ, Tobias AM, Lee BT. Patient satisfaction in postmastectomy breast reconstruction: a comparative evaluation of DIEP, TRAM, latissimus flap, and implant techniques. Plast Reconstr Surg. 2010 Jun;125(6):1585-1595. doi: 10.1097/PRS.0b013e3181cb6351.
Lam TC, Hsieh F, Boyages J. The effects of postmastectomy adjuvant radiotherapy on immediate two-stage prosthetic breast reconstruction: a systematic review. Plast Reconstr Surg. 2013 Sep;132(3):511-518. doi: 10.1097/PRS.0b013e31829acc41.
He S, Yin J, Robb GL, Sun J, Zhang X, Li H, Liu J, Han C. Considering the Optimal Timing of Breast Reconstruction With Abdominal Flaps With Adjuvant Irradiation in 370 Consecutive Pedicled Transverse Rectus Abdominis Myocutaneous Flap and Free Deep Inferior Epigastric Perforator Flap Performed in a Chinese Oncology Center: Is There a Significant Difference Between Immediate and Delayed? Ann Plast Surg. 2017 Jun;78(6):633-640. doi: 10.1097/SAP.0000000000000927.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
E2018210
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.