Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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.

hypofractionated radiation

Jiayi Chen, MD

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.

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.

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

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.

Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed every 6 months during the first 2 years and annually thereafter using the RTOG/ (European Organization for Research on Treatment of Cancer) EORTC Late Radiation Morbidity Scoring Schema and CTCAE 3.0

The time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast.

The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30 and QLQ-BR23.

Any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area (including supraclavicular, infraclavicular or internal mammary lymph nodes)

The time from the date of randomization to any recurrence of tumor at distant sites or death from any cause.

The time from the date of randomization to any invasive recurrence of tumor or death from any cause.

The time from the date of randomization to the date of death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam	NCT05486936	Breast Cancer	hypofractionate...	18 Years - 75 Years	Ruijin Hospital
RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam	NCT05486936	Breast Cancer	hypofractionate...	18 Years - 75 Years	Ruijin Hospital

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