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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210623004

Enrollment

Registered

2021-06-23

Start date

2020-07-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Whole breast irradiation (WBI) with simultaneous integrated boost (SIB) technique treated by Helical TomoTherapy. The radiation dose for 16 fractions with 2.65 Gy/fraction to 42.4 Gy to the PTV whole

Experimental Radiation

Simultaneous Integrated Boost (SIB) technique

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactImjai Chitapanarux

Faculty of Medicine, Chiang Mai University

imjaie@hotmail.com053935456

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026