Clinical trial NCT05486936: RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam
Official title: RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: hypofractionated radiotherapy
IMRT
internal mammary nodes
rapidplan model
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 195
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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. CTV including breast/chest wall and regional nodes will be contoured according to RTOG contouring atlas. Integrated multi-beam IMRT plan will be generated and optimized using our predefined protocol for OAR constrains and target coverage. All integrated IMRT plans will be designed using the Eclipse™ Treatment Planning System. All these tight margin IMRT plan will be passed in pre-treatment dry run with the motion management workflow involved and the target coverage during the treatment will be confirmed. The plans which pass the above 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: ≥Grade 2 acute radiation-induced toxicity
timeFrame: 6 months
Secondary outcomes:
measure: ≥Grade 2 Late Radiation-induced Toxicity
timeFrame: 5 years
measure: Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale
timeFrame: 5 years
measure: Quality of Life-EORTC QLQ-C30 and QLQ-BR23
timeFrame: 1 years
measure: Quality of Life-EORTC QLQ-C30 and QLQ-BR23
timeFrame: 5 years
measure: Locoregional recurrence (LRR)
timeFrame: 5 years
measure: distant metastasis free survival (DMFS)
timeFrame: 5 years
measure: invasive recurrence free survival (IRFI)
timeFrame: 5 years
measure: overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jiayi Chen, MD
role: STUDY_CHAIR
References: