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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
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

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

First Posted
May 30, 2021
Last Updated
August 25, 2021
Sponsor
Capital Medical University
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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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