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

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

NCT03856372

Breast Cancer

RECRUITING NA

Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

NCT01413269

Breast Cancer

COMPLETED PHASE3

Hypofractionated vs Conventional RT After Prosthetic Breast Reconstruction

NCT07084519

Breast Cancer Breast Reconstruction Radiation Oncology

NOT_YET_RECRUITING PHASE3

Post Mastectomy Hypofractionated Radiotherapy in High Risk Breast Cancer

NCT03319069

Breast Cancer

UNKNOWN PHASE3

Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

NCT05762900

Breast Cancer Radiotherapy Side Effect

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Eligible breast cancer patients with mastectomy and axillary dissection are randomized into 2 groups:conventional fractionation radiotherapy of 50 Gy in 25 fractions within 5 weeks to ipsilateral chest wall and supraclavicular nodal region,and hypofractionation radiotherapy of 43.5Gy in 15 fractions within 3 weeks to the same region.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hypofractionation radiotherapy

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

Group Type EXPERIMENTAL

hypofractionation radiotherapy

Intervention Type RADIATION

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

conventional fractionation radiotherapy

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

Group Type ACTIVE_COMPARATOR

conventional fractionation radiotherapy

Intervention Type RADIATION

50Gy/25/f/5w

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hypofractionation radiotherapy

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

Intervention Type RADIATION

conventional fractionation radiotherapy

50Gy/25/f/5w

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

radiotherapy radiotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No