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

NCT ID: NCT05762900

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2030-10-25

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.

Conditions

Breast Cancer; Radiotherapy Side Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultra-hypofractionated arm

The patients will be treated by Ultra-hypofractionated irradiation.

Group Type: EXPERIMENTAL

Ultra-fractionated radiation therapy

Intervention Type: RADIATION

5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.

Interventions

Ultra-fractionated radiation therapy

5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.

Intervention Type: RADIATION

Other Intervention Names

Simultaneous Integrated Boost

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with invasive or non-invasive breast cancer;

2. The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;

3. Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).

4. No distant metastasis;

5. Life expectancy ≥6 months;

6. 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.);

7. Patients are willing to cooperate to follow up;

8. Patients should sign the informed consent;

9. Women of childbearing age need effective contraception.

Exclusion Criteria

1. Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.

2. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;

3. Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;

4. Concurrent active connective tissue disease;

5. 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);

6. 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).

7. Pregnant or breast-feeding.

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

HAO JING

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shu-Lian Wang, M.D.

Role: CONTACT

wangsl@cicams.ac.cn

8610-87788290

Facility Contacts

Hao Jing, M.D.

Role: primary

owletskim@163.com

8610-87788281

Other Identifiers

22/409-3611

Identifier Type: -

Identifier Source: org_study_id