Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer

Sponsor

Capital Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04913532

Collaborator

(none)

Enrollment

Location

Arm

49.3

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Surgery Adjuvant Radiotherapy	Radiation: Hypofractionation with simultaneous integrated boost	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 22, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypofractionation with SIB Hypofractionation with SIB	Radiation: Hypofractionation with simultaneous integrated boost Hypofractionation with simultaneous integrated boost

Arm

Intervention/Treatment

Experimental: Hypofractionation with SIB

Hypofractionation with SIB

Radiation: Hypofractionation with simultaneous integrated boost

Hypofractionation with simultaneous integrated boost

Outcome Measures

Primary Outcome Measures

Acute Toxicity [6 months]
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE

Secondary Outcome Measures

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

Other Outcome Measures

Skin toxicity (Cosmetic results) [0 to 6 months]
RTOG

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Shijitan Hospital	Beijing		China	100038

Sponsors and Collaborators

Capital Medical University

Investigators

Principal Investigator: Wenjie Ni, MD., Beijing Shijitan Hospital, Capital Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wenjie Ni, Capital Medical University, Capital Medical University

ClinicalTrials.gov Identifier:

NCT04913532

Other Study ID Numbers:

2020-q12

First Posted:

Jun 4, 2021

Last Update Posted:

Aug 26, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Aug 26, 2021