Super-Hypofractionated Partial Breast Irradiation

NCT06615466 | Recruiting

• 1 other identifier: NCC-008224; 22/117-3318
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Partial breast irradiation is currently a hot topic in clinical research, but the appropriate population and appropriate irradiation The technology and dose fractionation mode are still inconclusive. Foreign studies have mostly selected patients with low risk of recurrence. Breast-conserving surgeries for early-stage breast cancer are increasing year by year in China. It is necessary to conduct prospective clinical studies to explore the Chinese population suitable for partial breast irradiation and the appropriate radiotherapy dose fractionation model. A preliminary study in our center has compared the safety and efficacy of a 2-week schedule of partial breast irradiation (40Gy/10f) and a 3-week schedule of whole-breast radiotherapy (43.5Gy/15f) in patients with early-stage low-risk breast cancer after breast-conserving surgery. , preliminary results show that the 2-week partial breast irradiation regimen is safe and effective. This study plans to continue to select low-risk breast-conserving patients, use extracorporeal intensity-modulated radiotherapy technology, refer to the radiotherapy dose fractionation model of the FAST-Forward study, and give partial breast irradiation 5.2 Gy/f/d, a total of 5 times, with a total dose of 26Gy, to further shorten the time The radiotherapy time is 1 week, and the acute and late adverse reactions of radiotherapy and the local control of the tumor are prospectively observed. Provide evidence for conducting a national multi-center phase III clinical randomized study.

Conditions

Breast Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (1)

• Incidence of acute adverse reactions

  up to 6 months

Secondary Outcomes (2)

• Incidence of late adverse reactions

  through study completion, an average of 5 year

• Survival

  through study completion, an average of 5 year

Study Arms (1)

Partial Breast Irradiation

EXPERIMENTAL

Radiation: Partial Breast Irradiation

Interventions

Partial Breast Irradiation RADIATION

26Gy/5.2Gy/5f

Partial Breast Irradiation

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥45 years old, \<75 years old women
• Life expectancy \>5 years
• Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8 weeks from the end of chemotherapy)
• Invasive ductal carcinoma grade 1-2, or mucinous carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor
• ≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)
• Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
• Single focus (with MRI diagnosis)
• Vascular tumor thrombus negative
• ER and/or PR positivity (defined as strong positivity in \>1% of tumor cell nuclei)
• Negative pathological margin≥2mm
• Place metal markers on the tumor bed
• Sign the informed consent form

You may not qualify if:

• Multiple primary tumors
• Invasive ductal carcinoma grade 3
• Invasive micropapillary carcinoma
• Lobular carcinoma in situ
• Invasive lobular carcinoma
• Simple nipple paget's disease
• Oncoplastic surgery
• Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
• Previous or simultaneous contralateral breast cancer
• History of ipsilateral chest wall radiotherapy
• Have active collagen vascular disease

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guangyi Sun

CONTACT

086-18811100731; sungy@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: September 26, 2024
• Study Start: April 22, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-04

Locations

CN (1)