Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04913532
• Other study ID #: 2020-q12
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2021
• Source: Capital Medical University
• Contact: Wenjie Ni, MD.
• Phone: 8613661171730
• Email: niwenjie_1990[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Radiotherapy
• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Radiation:
• Hypofractionation with simultaneous integrated boost
Hypofractionation with simultaneous integrated boost

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin toxicity (Cosmetic results)	RTOG	0 to 6 months
Primary	Acute Toxicity	Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE	6 months
Secondary	Feasibility of the radiation plan	Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy	19 days
Secondary	other acute Toxicity	All dimensions of NCI-CTCAE/RTOG	0-6 months