Postoperative hypofractionation and simultaneous integrated boost with or without regional nodal irradiation by TomoTherapy for breast cancer

Phase 2

Recruiting

• Conditions: Breast cancer patients after breast conserving surgery with or without adjuvant chemotherapy; breast cancer; hypofractionation; simultaneous integrated boost; TomoTherapy

• Registration Number: TCTR20210623004
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-23
• Study Completion: 2022-07-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

1. Received breast conserving surgery (BCS)
2. With or without the indication for regional nodal irradiation (RNI)
3. Pathologically confirmed breast cancer
4. Free surgical margins from both invasive carcinoma and ductal carcinoma in situ (DCIS)
5. Indication for tumor bed boost according institutional protocol
(age < 50 years or age > 50 years with high risk features)
6. Clearly identified primary tumor region preferably by radiopaque clips
7. Surgical wound healing without signs of infection
8. Age 18 years old or more
9. ECOG performance status 0-1
10. Written informed consent
11. Compliance regarding to follow up

Exclusion Criteria

1. Patients received mastectomy
2. No indication for boost radiation
3. Inadequate identification of the boost volume
4. Bilateral breast cancer
5. History of prior breast or thoracic radiotherapy
6. Extended postoperative seroma at the beginning of radiotherapy
7. Pregnant or lactating patients
8. Treatment history of other cancer
9. Patients with serious, uncontrolled, physical or cerebrovascular disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute toxicity During radiation RTOG/EORTC acute and late radiation morbidity score,Late toxicity From 3 months after end of the radiation RTOG/EORTC acute and late radiation morbidity score,Arm lymphedema From 3 months after end of the radiation Staging by the International Society of Lymphology (ISL),Cosmetic result From 3 months after end of the radiation Questionnaire of Vargus et al.

Secondary Outcome Measures

Name	Time	Method
2-year in field boost recurrence (IFBR) rate at 24 months after end of the intervention Kaplan-Meier method ,2-year locoregional recurrence (LRR) rate at 24 months after end of the intervention Kaplan-Meier method