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NCT06757621
Hypofractionated Postoperative Regional Nodal Irradiation for Patients With Intermediate-risk Breast Cancer
Phase 3 trial testing Regional Nodal Irradiation in Breast Carcinoma in 3,142 participants. Currently enrolling.
1 November 2029
Quick facts
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3,142 |
| Start date | 10 October 2024 |
| Primary completion | 1 November 2029 |
| Estimated completion | 1 November 2032 |
| Sites | 1 location across China |
Drugs / interventions tested
- Regional Nodal Irradiation
Conditions studied
- Breast Carcinoma — all drugs for Breast Carcinoma →
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.
Verify or expand the search:
- PubMed search for NCT06757621
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Related trials
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Trials testing the same drug.
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Currently open trials in the same condition.
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Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy · NA · not yet recruiting
- NCT07537049 — BR101 in Patients With Relapsed/Refractory Multiple Myeloma · Phase 1 · not yet recruiting
- NCT07187154 — The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy · NA · not yet recruiting
- NCT07530549 — A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Che · Phase 2 · not yet recruiting
- NCT07507058 — Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06757621 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Last refreshed: 3 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06757621.
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