RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam

NCT05486936 | Unknown

• 1 other identifier: RJrapidplan
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to establish a feasible DVH estimation model of integrated IMRT plan for HF-RNI with Eclipse™ Treatment Planning System and a Varian RapidPlan™ model based on the above DVH constraints.

Conditions

Breast Cancer

Keywords

hypofractionated radiotherapy; IMRT; internal mammary nodes; rapidplan model

Outcome Measures

Primary Outcomes (1)

• ≥Grade 2 acute radiation-induced toxicity

  Within time from beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicity will be assessed every week during radiotherapy, 4 weeks, 3 months and 6 months after the last fraction received using the (Common Terminology Criteria for Adverse Events) CTCAE 3.0 and recorded.

  6 months

Secondary Outcomes (8)

• ≥Grade 2 Late Radiation-induced Toxicity

  5 years

• Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale

  5 years

• Quality of Life-EORTC QLQ-C30 and QLQ-BR23

  1 years

• Quality of Life-EORTC QLQ-C30 and QLQ-BR23

  5 years

• Locoregional recurrence (LRR)

  5 years

Study Arms (1)

study arm

Eligible breast cancer patients will receive hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) at the discrection of radition oncologists. The plans which pass the on-line verification will then be de-identified and transferred to RapidPlan configuration workspace for RNI model training and verification.All enrolled patients will be regularly followed up during and after RT. Acute and late toxicity will be documented as well as tumor control endpoints.

Radiation: hypofractionated radiation

Interventions

hypofractionated radiation RADIATION

Eligible breast cancer patients will receive hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) at the discrection of radition oncologists.

study arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited by radiation oncologists in outpatient department. For each potential participant, the background of this trial will be introduced by the clinicians or research nurses at their first visit.

You may qualify if:

• Aged 18-75 years old
• Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer pT1-3
• ≥1 pathologically positive axillary lymph nodes
• Karnofsky Performance Status scoring ≥80
• Surgery wound healed without infection
• Anticipative overall survival \>5 years
• Pathologically surgical margin \>2mm
• ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
• Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation
• Ability to understand and willingness to participate the research and sign the consent form

You may not qualify if:

• Axillary dissection of less than 10 lymph nodes
• Pathologically positive ipsilateral supraclavicular lymph node
• Pathologically or radiologically confirmed positive ipsilateral internal mammary lymph nodes
• Pregnant or lactating women
• Treated with breast reconstruction surgery
• Severe non-neoplastic medical comorbidities
• History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix
• simultaneous contralateral breast cancer
• Previous RT to the neck, chest and/or ipsilateral axillary region
• Active collagen vascular disease
• Definitive pathological or radiologic evidence of distant metastatic disease
• Primary T4 tumor
• Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Jiayi Chen, MD

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

Jiayi Chen, MD

CONTACT

+86-021-64370045; cjy11756@rjh.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Radiation Oncology

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 4, 2022
• Study Start: December 15, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

CN (1)