A Phase Ⅲ Randomized Clinical Trial of Postmastectomy Hypofractionation Radiotherapy in High-risk Breast Cancer

NCT00793962 | Completed Phase 3 DMC

• 1 other identifier: LC2008A06
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy and toxicities of hypofractionation radiotherapy with conventional fractionation radiotherapy in breast cancer patients treated with mastectomy.It is hypothesized that the efficacy and toxicities are similar between the two groups.

Conditions

Breast Cancer

Keywords

breast cancer; mastectomy; radiotherapy; fractionation

Outcome Measures

Primary Outcomes (1)

• locoregional control rate

  ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse

  5 years

Secondary Outcomes (1)

• overall survival

  5 years

Study Arms (2)

hypofractionation radiotherapy

EXPERIMENTAL

breast cancer women with mastectomy high-risk: T3-4 and/or 4 or more axillary nodes involvement postmastectomy hypofractionation radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region

Radiation: hypofractionation radiotherapy

conventional fractionation radiotherapy

ACTIVE COMPARATOR

breast cancer women with mastectomy high-risk with T3-4 and/or 4 or more axillary nodes postmastectomy conventional fractionation radiotherapy of 50Gy/25f/5w to the chest wall and supraclavicular nodal region

Radiation: conventional fractionation radiotherapy

Interventions

hypofractionation radiotherapy RADIATION

radiotherapy of 43.5Gy/15f/3w to the chest wall and supraclavicular nodal region

Also known as: radiotherapy

hypofractionation radiotherapy

conventional fractionation radiotherapy RADIATION

50Gy/25/f/5w

Also known as: radiotherapy

conventional fractionation radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ipsilateral histologically confirmed invasive breast cancer
• Undergone total mastectomy and axillary dissection
• T3-4,or \>=4 positive axillary lymph nodes
• Fit for chemotherapy(if indicated),endocrine therapy(if indicated)and postoperative irradiation
• Written,informed consent
• cT3-4,or cN2, or pathological positive axillary lymph nodes during mastectomy for patients who had received neoadjuvant chemotherapy or hormone therapy
• no supraclavicular or internal mammary nodes metastases
• no distant metastases
• enrollment date no more than 8 months after surgery or no more than 2 months after chemotherapy for patients who didn't receive neoadjuvant systemic therapy.
• enrollment date no more than 2 months after surgery for patients who had received neoadjuvant systemic therapy and didn't need adjuvant chemotherapy.

You may not qualify if:

• Patients who undergone previous irradiation to the ipsilateral chest wall and supraclavicular region
• Previous or concurrent malignant other than non-melanomatous skin cancer
• Unable or unwilling to give informed consent
• bilateral breast cancer
• immediate or delayed ipsilateral breast cancer reconstruction

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (2)

• Yang J, Qi SN, Fang H, Song YW, Jin J, Liu YP, Wang WH, Yang Y, Tang Y, Ren H, Chen B, Lu NN, Tang Y, Li N, Jing H, Wang SL, Li YX. Cost-effectiveness of postmastectomy hypofractionated radiation therapy vs conventional fractionated radiation therapy for high-risk breast cancer. Breast. 2021 Aug;58:72-79. doi: 10.1016/j.breast.2021.04.002. Epub 2021 Apr 19.

  PMID: 33933925 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Therapeutics

Study Officials

• shu-lian wang, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Ye-xiong Li, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CN (1)