CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 801 target
Drug / intervention
Hypofractionated radiotherapy +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age 18-75 years old
  • ✓Unilateral histologically confirmed invasive breast carcinoma pT1-3
  • ✓Breast conservation surgery or mastectomy performed
  • ✓Histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection allowed)
Key exclusion· 10
  • ✕Supraclavicular lymph nodes involvement
  • ✕Positive ipsilateral internal mammary lymph nodes
  • ✕Residual axillary nodes eligible for boost dose
  • ✕Pregnant or lactating

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03829553
NCT03829553Phase 3RecruitingUpdate OverdueUpdated 48mo ago · Completion was 43mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Hypofractionated Versus Conventional Intensity-Modulated Radiation Therapy for Breast Cancer Patients With an Indication for Regional Nodal Irradiation: A Randomized Multi-center Phase III Trial

Ruijin Hospital·interventional·Posted Feb 4, 2019·Updated Jun 2, 2022

In Brief

A Phase 3 clinical trial evaluating Hypofractionated radiotherapy and Conventional radiotherapy for Breast Cancer. Currently recruiting, targeting 801 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
CollaboratorsRenJi Hospital, Shanghai 10th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Zhongshan Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Affiliated Hospital of Jiangnan University, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Timeline

Phase 3Recruiting
2019202020212022202320242025202620272028
First PostedFeb 4, 2019
Enrollment StartFeb 21, 2019
Primary CompletionDec 1, 2022
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.4 years ago

Interventions

Hypofractionated radiotherapyradiation

4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

Conventional radiotherapyradiation

5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast