Safety and Efficacy of IMPT or IMRT for Breast Cancer

NCT06826885 | Recruiting

• 1 other identifier: RJBC- SEPPT-BC
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare the toxicities and efficacy of intensity-modulated proton therapy (IMPT) and intensity-modulated radiation therapy (IMRT) for breast cancer patients indicated for radiotherapy including preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy. IMPT or IMRT will be administered to the whole breast, chest wall, and/or regional lymph nodes. A boost dose will be delivered in patients with high-risk area, at the discretion of the radiation oncologist. Eligible breast cancer patients will be followed for at least 5 years to assess acute and late radiation induced toxicities, loco-regional recurrence, overall survival, distant metastasis, and quality of life.

Conditions

Breast Cancer; Proton Therapy; Intensity Modulated Radiation Therapy; Efficacy and Safety; Radiotherapy, Adjuvant

Keywords

postoperative radiotherapy; preoperative radiotherapy; IMPT; IMRT; breast cancer; efficacy; toxicity

Outcome Measures

Primary Outcomes (1)

• Complication Rate of ≥Grade 2 Acute Radiation-Induced Toxicity

  Acute radiation-induced toxicities will be assessed and recorded from the start of radiotherapy to six months after its completion. Evaluations will occur weekly during treatment, and at 2 weeks, 4 weeks, 3 months, and 6 months post-treatment. The assessment will utilize the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  6 months

Secondary Outcomes (9)

• Complication Rate of ≥Grade 2 Late Radiation-induced Toxicity

  5 years

• Locoregional recurrence

  5 years

• Distant Metastasis-Free Survival (DMFS)

  5 years

• Invasive Recurrence-Free Survival (iRFS)

  5 years

• Overall Survival (OS)

  5 years

Other Outcomes (3)

• Quality of Life using self-administered questionnaire EORTC QLQ-C30

  5 years

• Number of Participants with Excellent or Good Cosmetic Outcomes Following Breast-Conserving Surgery

  5 years

• Patient-Reported Outcomes (PRO) survey

  5 years

Study Arms (3)

Arm1: Postoperative radiotherapy

Patients who indicated postoperative radiotherapy using IMRT or IMPT.

Radiation: Postoperative radiotherapy

Arm2：Preoperative radiotherapy

Patients who indicated preoperative radiotherapy using IMRT or IMPT.

Radiation: Preoperative Radiotherapy

Arm3：Definitive radiotherapy

Patients who indicated definitive radiotherapy using IMRT or IMPT.

Radiation: Definitive Radiotherapy

Interventions

Postoperative radiotherapy RADIATION

Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed. A tumor bed boost will be provided to patients with high-risk factors following breast-conserving surgery, at the discretion of the radiation oncologist. The tumor bed boost regimen may consist of a sequential boost of 10-16 Gy (RBE) in 5-8 fractions, or 10-13.35 Gy (RBE) in 4-5 fractions or 10.4 Gy (RBE) in 2 fractions, or a simultaneous integrated boost of 48-49.5 Gy (RBE) in 15-16 fractions.

Arm1: Postoperative radiotherapy

Preoperative Radiotherapy RADIATION

Radiotherapy was administered using IMPT or IMRT. The target volume includes the ipsilateral whole breast, chest wall, and/or regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions is preferred. A conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions is also allowed.

Arm2：Preoperative radiotherapy

Definitive Radiotherapy RADIATION

Radiotherapy was delivered using IMPT or IMRT. The target volume encompassed the ipsilateral whole breast and regional lymph nodes. A hypofractionated regimen of 40-42.5 Gy (RBE) in 15-16 fractions was preferred. Alternatively, a conventional fractionated regimen of 45-50.4 Gy (RBE) at 1.8-2 Gy per fraction in 25-28 fractions or an ultra-hypofractionated regimen of 26 Gy (RBE) in 5 fractions was permitted. Dose escalation was applied in high-risk areas, resulting in a total prescribed dose exceeding 66 Gy (RBE) when calculated as equivalent doses in 2-Gy fractions (EQD2), with an α/β ratio of 4.

Arm3：Definitive radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients aged ≥18 years with histologically confirmed disease and indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy, as determined by the treating physician, who are willing to receive radiotherapy using IMPT or IMRT.

You may qualify if:

• Aged ≥18 years old
• Karnofsky Performance Status (KPS) score ≥70
• Histologically confirmed breast cancer with indications for preoperative radiotherapy, postoperative radiotherapy, or definitive radiotherapy as determined by the treating physician.
• ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), and Ki67 testing must be performed on the primary breast tumor.
• Women of child-bearing potential must agree to use adequate contraception starting 1 month before study treatment and throughout the duration of study participation.
• Ability to understand and willingness to participate in the research and sign the informed consent form.

You may not qualify if:

• Pregnant or lactating women.
• Severe non-neoplastic medical comorbidities that may interfere with treatment or study participation.
• Active collagen vascular disease or other autoimmune disorders that could significantly increase the risk of radiation toxicity.
• Patients with contraindications to undergoing IMPT or IMRT, such as severe claustrophobia that cannot be managed or inability to remain immobilized during treatment.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shandong Cancer Hospital and Institute: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Gang Cai, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jia-Yi Chen, PhD, MD

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Gang Cai, MD

CONTACT

+86-021-64370045; cg11855@rjh.com.cn

Lu Cao, PhD, MD

CONTACT

+86-021-64370045; chenjiayi0188@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Radiation Oncology Department

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: February 14, 2025

Record last verified: 2024-12

Locations

CN (1)