Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Primary Purpose
Breast Cancer, Surgery, Adjuvant Radiotherapy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hypofractionation with simultaneous integrated boost
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Beijing Shijitan HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypofractionation with SIB
Arm Description
Hypofractionation with SIB
Outcomes
Primary Outcome Measures
Acute Toxicity
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Secondary Outcome Measures
Feasibility of the radiation plan
Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy
other acute Toxicity
All dimensions of NCI-CTCAE/RTOG
Full Information
NCT ID
NCT04913532
First Posted
May 30, 2021
Last Updated
August 25, 2021
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04913532
Brief Title
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Official Title
A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Surgery, Adjuvant Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionation with SIB
Arm Type
Experimental
Arm Description
Hypofractionation with SIB
Intervention Type
Radiation
Intervention Name(s)
Hypofractionation with simultaneous integrated boost
Intervention Description
Hypofractionation with simultaneous integrated boost
Primary Outcome Measure Information:
Title
Acute Toxicity
Description
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Feasibility of the radiation plan
Description
Dose constraints Dmean lung < 10 Gy; Dmean heart < 5 Gy, Dmedian contralateral breast < 4Gy
Time Frame
19 days
Title
other acute Toxicity
Description
All dimensions of NCI-CTCAE/RTOG
Time Frame
0-6 months
Other Pre-specified Outcome Measures:
Title
Skin toxicity (Cosmetic results)
Description
RTOG
Time Frame
0 to 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjie Ni, MD.
Phone
8613661171730
Email
niwenjie_1990@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjie Ni, MD.
Organizational Affiliation
Beijing Shijitan Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjie Ni
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No.
Learn more about this trial
Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
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