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

NCT05762900 | Recruiting Phase 2

• 1 other identifier: 22/409-3611
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Radiotherapy Side Effect

Keywords

Breast cancer; Ultra-fractionated radiotherapy; Toxicity; Lymph-drainage region irradiation

Outcome Measures

Primary Outcomes (1)

• 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.

  until 12 weeks from the completion of postoperative radiotherapy

Secondary Outcomes (8)

• Local recurrence rate

  Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.

• Local regional recurrence rate

  Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.

• Disease-free survival

  Until at least 5 years after diagnosis.

• Overall survival

  Until at least 5 years after diagnosis.

• The rate of patients who develop radiation-associated long-term toxicity

  From 12 weeks to 5 years post radiotherapy.

Study Arms (1)

Ultra-hypofractionated arm

EXPERIMENTAL

The patients will be treated by Ultra-hypofractionated irradiation.

Radiation: Ultra-fractionated radiation therapy

Interventions

Ultra-fractionated radiation therapy RADIATION

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

Also known as: Simultaneous Integrated Boost

Ultra-hypofractionated arm

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Central Study Contacts

Shu-Lian Wang, M.D.

CONTACT

8610-87788290; wangsl@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: The treatment is not a drug.

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 10, 2023
• Study Start: October 25, 2022
• Primary Completion: October 25, 2025
• Study Completion (Estimated): October 25, 2030
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

CN (1)