A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.
NCT ID: NCT06677879
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
780 participants
INTERVENTIONAL
2024-08-01
2028-07-31
Brief Summary
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1. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after breast-conserving surgery?
2. What is the difference in the incidence of radiation-related grade 2 or higher adverse events within two years following proton versus photon therapy after mastectomy?
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Proton therapy
Proton radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.
Proton radiotherapy
Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE).
Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week.
photon therapy
Photon radiotherapy will be offered to patients who require adjuvant radiotherapy after lumpectomy or mastectomy for breast cancer.
Photon radiotherapy
Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE).
Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.
Interventions
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Proton radiotherapy
Lumpectomy group: The total dose was 40.05Gy (RBE) , 2.67Gy (RBE) per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE).
Mastectomy group: The total dose was 42.56Gy (RBE) , 2.66Gy (RBE) per fraction with 16 fractions. Once a day, five times a week.
Photon radiotherapy
Lumpectomy group: The total dose was 40.05Gy, 2.67Gy per fraction with 15 fractions. Once a day, five times a week. The tumor bed SIB to 48Gy (RBE).
Mastectomy group: The total dose was 42.56Gy, 2.66Gy per fraction with 16 fractions. Once a day, five times a week.
Eligibility Criteria
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Inclusion Criteria
2. Indications for adjuvant radiotherapy following lumpectomy or mastectomy for left breast cancer:
1. Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.
2. Post mastectomy: Patients who have undergone mastectomy, with postoperative pathology staged as pT1-3 N1-3, excluding N3c, and who have had an implant (prosthesis or tissue expander) placed.
3. Neoadjuvant therapy patients: Patients who have received neoadjuvant chemotherapy or endocrine/targeted therapy and have a postoperative stage of ypT1-3 N0-3, excluding N3c, requiring radiotherapy to the chest wall/breast and regional lymphatic drainage areas.
4. No distant metastasis.
5. Age range: 18-80 years.
6. Performance status: Eastern Cooperative Oncology Group (ECOG) score of 0-2.
7. Non-pregnant and non-lactating women.
8. Informed consent: Patients must provide written informed consent prior to receiving radiotherapy.
Exclusion Criteria
2. Tumor staging: Patients presenting with T4, N0, or N3c disease.
3. History of prior radiotherapy to the ipsilateral chest or breast.
4. Surgical margin status: Margins are either positive or close, defined as:
Invasive carcinoma within 1 mm of the surgical margin.
5. Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.
18 Years
80 Years
FEMALE
No
Sponsors
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Shanghai Proton and Heavy Ion Center
OTHER
Responsible Party
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Qing Zhang,MD
professor
Locations
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Shanghai Proton and Heavy Ion Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Jin Meng, Ph.D
Role: backup
Other Identifiers
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SPHIC-TR-BCa2024-01
Identifier Type: -
Identifier Source: org_study_id
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