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NCT06757621

Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer

Recruiting now Phase 3 Last updated 3 January 2025
What this trial tests

Phase 3 trial testing Regional Nodal Irradiation in Breast Carcinoma in 3,142 participants. Currently enrolling.

Timeline
10 October 2024
Primary endpoint
1 November 2029
1 November 2032

Quick facts

Lead sponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment3,142
Start date10 October 2024
Primary completion1 November 2029
Estimated completion1 November 2032
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Who can join

45 and older, female only, with Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The role of postoperative regional nodal irradiation (RNI) for T1-2N1 intermediate-risk breast cancer is controversial, and there is a lack of class I evidence of a survival benefit from RNI. A number of retrospective studies of breast cancer patient been undertaken to risk stratify, analyse site of recurrence and assess the role of radiotherapy. RNI is currently recommended for patients at high risk of recurrence, but prospective studies in other patients are needed to assess the role of RNI. Two randomised phase III trials have confirmed the safety and efficacy of 15-fraction hypofractionated radiotherapy, while 5-fraction super-hypofractionated radiotherapy to further shorten the course of radiotherapy is a hotspot of current research. The present study aimed to investigate whether RNI improves the outcome of intermediate-risk breast cancer patients; and to assess the efficacy and toxicity of 15-fraction hypofractionated and 5-fraction super-hypofractionated radiotherapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Regional Nodal Irradiation

Trials testing the same drug.

Other recruiting trials for Breast Carcinoma

Currently open trials in the same condition.

Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

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Data sources for this page

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