Hypofractionated Radiation Fractionation in Breast Cancer Patients with Implant-Based Reconstruction

NCT06830083 | Recruiting

• 1 other identifier: First Affiliated Hospital, Nan
• Study Type: interventional
• Target: 840
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.

Conditions

Breast Cancer

Keywords

implant-based reconstruction surgery; hypofraction radiation therapy

Outcome Measures

Primary Outcomes (1)

• Major complication

  implant related complications requiring reoperation such as severe necrosis，severe infections, severe capsular contracture, implant rupture and implant exposure.

  From enrollment to the end of treatment at 24 months

Secondary Outcomes (4)

• Any breast-related complications

  From enrollment to the end of treatment at 24 months

• Absolute reconstruction failure

  From enrollment to the end of treatment at 24 months

• Oncologic outcomes

  From enrollment to the end of treatment at 5 years

• Cosmetic outcomes

  From enrollment to the end of treatment at 24 months

Study Arms (2)

conventional fraction radiotherapy

ACTIVE COMPARATOR

Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.

Radiation: Conventional fraction radiotherapy

hypofractioned radiotherapy

EXPERIMENTAL

Total dose of plan tumor volume is 4050 cGy，and each fraction will consist of 270 cGy per day. 15 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes.

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Hypofractionation regimen: Total dose to the chest wall and the regional lymph nodes is 4050 cGy, and each fraction consists of 270 cGy per day(daily, Monday through Friday )

Also known as: HF

hypofractioned radiotherapy

Conventional fraction radiotherapy RADIATION

Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the supraclavicular (with or without axillary) lymph nodes.

Also known as: CF

conventional fraction radiotherapy

Eligibility Criteria

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

You may qualify if:

• \. Pathological diagnosis of stage I-III breast cancer (non-T4), \>18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)

You may not qualify if:

• Auto-reconstruction surgery
• Clinical or pathological T4
• Both sides need radiotherapy
• Have a history of chest radiotherapy
• Pregnancy/lactation
• Participate in other drug clinical trials

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu Taizhou People's Hospital: collaborator
• Hunan Cancer Hospital: collaborator

Study Sites (1)

Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (9)

• Mutter RW, Giri S, Fruth BF, Remmes NB, Boughey JC, Harless CA, Ruddy KJ, McGee LA, Afzal A, Gao RW, Shumway DA, Vern-Gross TZ, Villarraga HR, Kenison SL, Kang Y, Wong WW, Stish BJ, Merrell KW, Yan ES, Park SS, Corbin KS, Vargas CE. Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial. Lancet Oncol. 2023 Oct;24(10):1083-1093. doi: 10.1016/S1470-2045(23)00388-1. Epub 2023 Sep 8.

  PMID: 37696281 BACKGROUND

• Wong JS, Uno H, Tramontano AC, Fisher L, Pellegrini CV, Abel GA, Burstein HJ, Chun YS, King TA, Schrag D, Winer E, Bellon JR, Cheney MD, Hardenbergh P, Ho A, Horst KC, Kim JN, Leonard KL, Moran MS, Park CC, Recht A, Soto DE, Shiloh RY, Stinson SF, Snyder KM, Taghian AG, Warren LE, Wright JL, Punglia RS. Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction: A Randomized Clinical Trial. JAMA Oncol. 2024 Oct 1;10(10):1370-1378. doi: 10.1001/jamaoncol.2024.2652.

  PMID: 39115975 BACKGROUND

• Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.

  PMID: 30711522 BACKGROUND

• Salvestrini V, Valzano M, Meattini I, Becherini C, Visani L, Francolini G, Morelli I, Bertini N, Orzalesi L, Bernini M, Bianchi S, Simontacchi G, Livi L, Desideri I. Anatomical assessment of local recurrence site in breast cancer patients after breast reconstruction and post-mastectomy radiotherapy: implications for radiation volumes and techniques. Radiol Med. 2024 Jun;129(6):845-854. doi: 10.1007/s11547-024-01812-z. Epub 2024 Apr 11.

  PMID: 38602657 BACKGROUND

• Wu ZY, Han HH, Kim HJ, Lee J, Chung IY, Kim J, Lee S, Han J, Eom JS, Kim SB, Gong G, Kim HH, Son BH, Ahn SH, Ko B. Locoregional recurrence following nipple-sparing mastectomy with immediate breast reconstruction: Patterns and prognostic significance. Eur J Surg Oncol. 2021 Jun;47(6):1309-1315. doi: 10.1016/j.ejso.2021.01.006. Epub 2021 Jan 13.

  PMID: 33495030 BACKGROUND

• Kaidar-Person O, Vrou Offersen B, Hol S, Arenas M, Aristei C, Bourgier C, Cardoso MJ, Chua B, Coles CE, Engberg Damsgaard T, Gabrys D, Jagsi R, Jimenez R, Kirby AM, Kirkove C, Kirova Y, Kouloulias V, Marinko T, Meattini I, Mjaaland I, Nader Marta G, Witt Nystrom P, Senkus E, Skytta T, Tvedskov TF, Verhoeven K, Poortmans P. ESTRO ACROP consensus guideline for target volume delineation in the setting of postmastectomy radiation therapy after implant-based immediate reconstruction for early stage breast cancer. Radiother Oncol. 2019 Aug;137:159-166. doi: 10.1016/j.radonc.2019.04.010. Epub 2019 May 17.

  PMID: 31108277 BACKGROUND

• Kim YH, Yang YJ, Lee DW, Song SY, Lew DH, Yang EJ. Prevention of Postoperative Complications by Prepectoral versus Subpectoral Breast Reconstruction: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2024 Jan 1;153(1):10e-24e. doi: 10.1097/PRS.0000000000010493. Epub 2023 Apr 4.

  PMID: 37010460 BACKGROUND

• Zhang X, Ning S, Zhang Y. Complications After Prepectoral Versus Subpectoral Breast Reconstruction in Patients Receiving Postmastectomy Radiation Therapy: A Systematic Review and Meta-Analysis. Aesthetic Plast Surg. 2024 Nov;48(21):4421-4429. doi: 10.1007/s00266-024-04096-w. Epub 2024 May 3.

  PMID: 38700543 BACKGROUND

• Jagsi R, Momoh AO, Qi J, Hamill JB, Billig J, Kim HM, Pusic AL, Wilkins EG. Impact of Radiotherapy on Complications and Patient-Reported Outcomes After Breast Reconstruction. J Natl Cancer Inst. 2018 Feb 1;110(2):157-65. doi: 10.1093/jnci/djx148.

  PMID: 28954300 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiangsu Province People's Hospital

CONTACT

86-025-68307676; 13770662828@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 17, 2025
• Study Start: January 30, 2025
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 1, 2033
• Last Updated: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)