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Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients (UNIQUE)

Primary Purpose

Breast Cancer, Radiotherapy Side Effect

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ultra-fractionated radiation therapy
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, Ultra-fractionated radiotherapy, Toxicity, Lymph-drainage region irradiation

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with invasive or non-invasive breast cancer; The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection; Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery). No distant metastasis; Life expectancy ≥6 months; Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.); Patients are willing to cooperate to follow up; Patients should sign the informed consent; Women of childbearing age need effective contraception. Exclusion Criteria: Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury; Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before; Concurrent active connective tissue disease; Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma); Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV). Pregnant or breast-feeding.

Sites / Locations

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultra-hypofractionated arm

Arm Description

The patients will be treated by Ultra-hypofractionated irradiation.

Outcomes

Primary Outcome Measures

The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.

Secondary Outcome Measures

Local recurrence rate
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast or chest wall.
Local regional recurrence rate
The incidence of recurrence in the ipsilateral breast/chest wall or the lymphatic nodal regions.
Disease-free survival
The time interval from diagnosis to any event of recurrence or death.
Overall survival
The time interval from diagnosis to death from any reason.
The rate of patients who develop radiation-associated long-term toxicity
The investigators will record the incidence of any long-term toxicities, such as skin or subcutaneous fibrosis, pain, breast distortion, brachial plexopathy, lymphodema, cardiac event, rib fracture, pulmonary fibrosis, and so on.
Quality of Life.
European Organization for Research and Treatment of Cancer General Quality of Life Questionnaire (brev: EORTC C-30) is used. The higher the score, the worse the situation, with the range of 28 to 112.
Quality of Life.
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (brev: EORTC BR-23) is used. The higher the score, the worse the situation, with the range of 23 to 92.
The cosmetic outcome.
Breast Cancer Treatment Outcome Scale 22 (brev: BCTOS 22) is used, for patients who receive breast conservative surgery. The higher the score, the worse the cosmesis, with the range of 22 to 88.

Full Information

First Posted
February 20, 2023
Last Updated
March 9, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05762900
Brief Title
Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients
Acronym
UNIQUE
Official Title
Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
October 25, 2025 (Anticipated)
Study Completion Date
October 25, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.
Detailed Description
During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiotherapy Side Effect
Keywords
Breast cancer, Ultra-fractionated radiotherapy, Toxicity, Lymph-drainage region irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
The treatment is not a drug.
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultra-hypofractionated arm
Arm Type
Experimental
Arm Description
The patients will be treated by Ultra-hypofractionated irradiation.
Intervention Type
Radiation
Intervention Name(s)
Ultra-fractionated radiation therapy
Other Intervention Name(s)
Simultaneous Integrated Boost
Intervention Description
5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.
Primary Outcome Measure Information:
Title
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
Description
The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.
Time Frame
until 12 weeks from the completion of postoperative radiotherapy
Secondary Outcome Measure Information:
Title
Local recurrence rate
Description
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast or chest wall.
Time Frame
Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Title
Local regional recurrence rate
Description
The incidence of recurrence in the ipsilateral breast/chest wall or the lymphatic nodal regions.
Time Frame
Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Title
Disease-free survival
Description
The time interval from diagnosis to any event of recurrence or death.
Time Frame
Until at least 5 years after diagnosis.
Title
Overall survival
Description
The time interval from diagnosis to death from any reason.
Time Frame
Until at least 5 years after diagnosis.
Title
The rate of patients who develop radiation-associated long-term toxicity
Description
The investigators will record the incidence of any long-term toxicities, such as skin or subcutaneous fibrosis, pain, breast distortion, brachial plexopathy, lymphodema, cardiac event, rib fracture, pulmonary fibrosis, and so on.
Time Frame
From 12 weeks to 5 years post radiotherapy.
Title
Quality of Life.
Description
European Organization for Research and Treatment of Cancer General Quality of Life Questionnaire (brev: EORTC C-30) is used. The higher the score, the worse the situation, with the range of 28 to 112.
Time Frame
European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life before and at 12, 24 and 60 months after radiotherapy.
Title
Quality of Life.
Description
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (brev: EORTC BR-23) is used. The higher the score, the worse the situation, with the range of 23 to 92.
Time Frame
The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy.
Title
The cosmetic outcome.
Description
Breast Cancer Treatment Outcome Scale 22 (brev: BCTOS 22) is used, for patients who receive breast conservative surgery. The higher the score, the worse the cosmesis, with the range of 22 to 88.
Time Frame
The cosmetic outcome will be evaluated before and at 12, 24 and 60 months after radiotherapy.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with invasive or non-invasive breast cancer; The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection; Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery). No distant metastasis; Life expectancy ≥6 months; Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.); Patients are willing to cooperate to follow up; Patients should sign the informed consent; Women of childbearing age need effective contraception. Exclusion Criteria: Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury; Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before; Concurrent active connective tissue disease; Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma); Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV). Pregnant or breast-feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Lian Wang, M.D.
Phone
8610-87788290
Email
wangsl@cicams.ac.cn
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Jing, M.D.
Phone
8610-87788281
Email
owletskim@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

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