Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients with an indication for regional nodal irradiation will receive 5.2 Gy in 5 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk) and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast.

2600cGy/ 5 fractions / 1 weeks to ipsilateral chest wall or whole breast and regional lymph regions and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast

External Beam radiotherapy using IMRT technique

Lu Cao, MD

Lu Cao, MD, PhD

Jia-Yi Chen, PhD

The purpose of this trial is to investigate the toxicities and efficacy of hypofractionated regional nodal radiotherapy (RNI) for one week in breast cancer patients treated with mastectomy or breast conserving surgery. Hypofractionated radiotherapy will be delivered to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). Eligible breast cancer patients will be followed for at least 1 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, over survival, distant metastasis, and quality of life.

Eligible breast cancer patients will receive hypofractionated radiotherapy of 5.2 Gy in 5 fractions within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast. The dose is prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. patients will be followed for at least 1 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, over survival, distant metastasis, and quality of life.

Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after RNI comparing to conventional radiotherapy and lost rate of follow up of 10%. In total 197 patients are needed to be recruited.

Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer

One-week Hypofractionated Radiotherapy in Breast Cancer Patients With an Indication for Regional Nodal Irradiation: Prospective, Single-arm Trial

Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30

Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23

Quality of life will be assessed before radiotherapy and 5 years after last fractions using self administered questionnaire EORTC QLQ-C30

Quality of life will be assessed before radiotherapy and 5 years after last fractions using self administered questionnaire EORTC QLQ-BR23

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

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

The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ 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 cosmetic outcomes will be evaluated at 5 years after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ 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

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 enrollment to any recurrence of tumor at distant sites or death from any cause

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

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

Ruijin Hospital

Associated professor of Department of Radiation Oncology

Patients with an indication for whole breast irradiation will receive 5.2 Gy in 5 fractions to whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist

2600cGy/ 5 fractions / 1 weeks to ipsilateral whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist

Lu Cao, PhD

Jiayi Chen, PhD

JiaYi Chen, PhD

The purpose of this trial is to investigate the safety and efficacy of super hypofractionated whole breast irradiation (SHF-WBI) in breast cancer patients treated with breast conserving surgery. Eligible breast cancer patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, distant metastasis, death, contralateral breast cancer and quality of life.

Eligible breast cancer patients will receive SHF-WBI of 5.2 Gy in 5 fractions to ipsilateral whole breast within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of the radiation oncologist. All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. Patients will be followed for at least 5 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, distant metastasis, death and quality of life.

Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after SHF-WBI comparing to hypofractionated whole breast irradiation(40-42.5Gy/15-16Fx) and lost rate of follow up of 10%. In total 217 patients are needed to be recruited.

Super Hypofractionated Irradiation For Whole Breast Treatment

Super Hypofractionated Irradiation For Whole Breast Treatment: A Prospective, Single-arm Trial

Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation induced toxicities will be assessed and recorded using Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed and recorded using the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 5.0

The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer	NCT04509648	Breast Cancer	External Beam r...	18 Years -	Ruijin Hospital
Super Hypofractionated Irradiation For Whole Breast Treatment	NCT04926766	Breast Cancer	External Beam r...	18 Years -	Ruijin Hospital

Spots Global Cancer Trial Database for external beam radiotherapy using imrt technique