Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Surgery; Adjuvant Radiotherapy
• Interventions: Radiation: Hypofractionation with simultaneous integrated boost

• Registration Number: NCT04913532
• Lead Sponsor: Capital Medical University

Brief Summary

Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.

Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.

Detailed Description

Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)

Study Timeline

• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-04
• Study Start: 2021-06-22
• Primary Completion: 2023-06-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
• Indication to adjuvant radiotherapy including boost radiotherapy
• Clearly identified primary tumor region preferably by radiopaque clips
• Primary wound healing after breast conserving therapy without signs of infection
• Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
• Written informed consent

Exclusion Criteria

• Patients operated by mastectomy
• No indication for boost radiation
• Resection margins positive for disease or insufficient identification of the boost volume
• Indication for radiotherapy of the regional lymph nodes
• History of prior breast or thoracic radiotherapy
• Extended postoperative seroma at the beginning of radiotherapy
• Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
• Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionation with SIB	Hypofractionation with simultaneous integrated boost	Hypofractionation with SIB

Primary Outcome Measures

Name	Time	Method
Acute Toxicity	6 months	Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

Secondary Outcome Measures

Name	Time	Method
Feasibility of the radiation plan	19 days	Dose constraints Dmean lung \< 10 Gy; Dmean heart \< 5 Gy, Dmedian contralateral breast \< 4Gy
other acute Toxicity	0-6 months	All dimensions of NCI-CTCAE/RTOG

Trial Locations

Locations (1)

Beijing Shijitan Hospital; 🇨🇳 Beijing, China