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A Prospective Cohort Study of Proton and Photon Therapy for Left-sided Breast Cancer.

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShanghai Proton and Heavy Ion Center

About this trial

The goal of this study is to investigate the differences in toxicity and efficacy between proton and photon hypofractionated radiotherapy following lumpectomy or mastectomy for breast cancer. The main questions it aims to answer are:

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed invasive breast cancer.

Post lumpectomy: Patients who have undergone lumpectomy with postoperative pathology staged as pT1-3 N1-3, excluding N3c.

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.

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.

Disqualifiers

Presence of Ductal Carcinoma In Situ (DCIS).

Tumor staging: Patients presenting with T4, N0, or N3c disease.

History of prior radiotherapy to the ipsilateral chest or breast.

Bilateral breast cancer: Patients with synchronous or previous contralateral breast cancer.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Proton radiotherapy

    Radiation

    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

    Radiation

    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.

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: Proton therapyExperimental treatment 1 intervention
Group B: photon therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The rate of patients who develop radiation-associated toxicity (≥ 2 degree) in 2 years

We will record the incidence of ≥ 2 degree radiation-associated toxicity, such as breast or chest wall oedema, dermatitis, breast pain, esophagitis, rib fracture, radiation pneumonia and hypothyroidism and so on. The incidence of all the above is the primary outcome.

Time frame
Until 2 years after radiotherapy

Secondary outcomes

1

Late toxicities after 2 years of radiotherapy

Evaluation of long-term adverse effects (greater than 2 years) after radiotherapy (including radiation pulmonary fibrosis, radiation skin fibrosis, rib fracture, brachial plexus injury, upper limb lymphedema, heart injury, hypothyroidism, etc.)

Time frame
Until 5 years after radiotherapy
2

Locoregional recurrence (LRR)

To estimate and compare the rate of local recurrence between the proton and photon arms

Time frame
Until 5 years after treatment.
3

Disease-free survival (DFS)

Disease-free survival, defined as number of days from surgery until the first occurrence of local recurrence, distant metastases, tumor-related death, death without prior progression, or end of follow-up.

Time frame
Until 5 years after treatment.
4

Overall survival (OS)

Overall survival time, defined as number of days from date of initial diagnosis until death or end of follow-up.

Time frame
Until 5 years after treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Proton and Heavy Ion Center

Lead sponsor

Source ClinicalTrials.gov
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