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Trial Title:
RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam
NCT ID:
NCT05486936
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
hypofractionated radiotherapy
IMRT
internal mammary nodes
rapidplan model
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
hypofractionated radiation
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.
Arm group label:
study arm
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiayi Chen, MD
Phone:
+86-021-64370045
Phone ext:
602400
Email:
cjy11756@rjh.com.cn
Investigator:
Last name:
Jiayi Chen, MD
Email:
Principal Investigator
Start date:
December 15, 2021
Completion date:
December 15, 2024
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486936