CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 1,494 target
Drug / intervention
Hypofractionated +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 14
  • ✓Female
  • ✓Age 18-75 years
  • ✓Pathologically confirmed invasive breast cancer
  • ✓Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes
Key exclusion· 13
  • ✕Concurrent or previous malignancy excluding basal or squamous cell carcinoma of skin
  • ✕Previous radiotherapy to chest wall or regional lymph node areas
  • ✕Severe non-malignant comorbidity in cardiovascular or respiratory system
  • ✕Medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis

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

Search/NCT03856372
NCT03856372N/ARecruitingUpdate OverdueUpdated 88mo ago · Completion was 33mo ago
Enrollment Stalled
Long Recruiting
Update Overdue
CompareCT.gov

Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial

Fudan University·interventional·Posted Feb 27, 2019·Updated Feb 27, 2019

In Brief

A clinical study evaluating Hypofractionated and Conventional for Breast Cancer. Currently recruiting, targeting 1,494 participants across 3 sites.

Signals

Enrollment appears stalled

Detailed Summary

The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--

Timeline

N/ARecruiting
20192020202120222023202420252026202720282029
First PostedFeb 27, 2019
Enrollment StartSep 1, 2018
Primary CompletionSep 30, 2023
Study CompletionOct 30, 2028
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.3 years ago

Interventions

Hypofractionatedradiation

daily fractions, five fractions per week.

Conventionalradiation

daily fractions, five fractions per week.