The purpose of this study is to compare the efficacy and toxicity of early stage endometrial cancer based on molecular classification and conventional risk stratification adjuvant therapy decision-making, and to provide high-quality evidence-based medical evidence for individualized adjuvant therapy selection under the guidance of fine stratification system of endometrial cancer.
This is an investigator-initiated prospective, national multicentre, phase III, randomised, open, non-inferiority clinical study. The study hypothesis is that adjuvant radiotherapy decision for early-stage endometrial cancer which is based on molecular classification can achieve de-escalation of adjuvant treatment without reducing local tumour control and survival, thereby potentially further reducing radiotherapy-related toxicity and improving quality of life, compared to using conventional risk stratification. The primary endpoint of this study is the 3-year local recurrence rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
624
High-dose rate vaginal brachytherapy (VBT) was delivered with a vaginal cylinder.For VBT administered alone, the dose is recommended: 3 fractions of 7 Gy or 5 fractions of 6 Gy or 6 fractions of 5 Gy. For VBT administered after completion of EBRT: 2-3 fractions of 4-6 Gy.
EBRT was delivered to the pelvic area using a total dose of 45-50.4Gy in 25-28 fractions over 5-6 weeks with the intensity-modulated radiotherapy (IMRT) technique, three-dimensional conformal radiotherapy (3D-CRT) modality
No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.
Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.
Loco-regional recurrence (LRR)
Loco-regional recurrence (LRR) is defined as the first recurrence in the vagina or pelvic cavity during follow-up, which was confirmed by imaging examination or biopsy pathology.
Time frame: 3-year
Failure free survival(FFS)
FFS is defined as the time from randomization to recurrence,distant metastasis or death from any cause,whichever is first.
Time frame: 3-year,5-year
Overall survical(OS)
Overall survival is calculated from randomization to death from any cause.
Time frame: 3-year,5-year
Cumulative vaginal recurrence
Recurrence in the vaginal area during follow-up
Time frame: 3-year,5-year
Cumulative pelvic recurrence
Recurrence in the pelvic area, including the vagina, during follow-up
Time frame: 3-year,5-year
Distance metastasis(DM)
Distant metastasis (such as bone, lung, liver, brain, non-pelvic regional lymph node metastasis).
Time frame: 3-year,5-year
De-escalation rate of treatment
Comparison of the proportion of patients in two groups with the same clinicopathologic factors (FIGO, G, LVSI, age) downgraded from EBRT to VBT or from adjuvant radiotherapy (EBRT or VBT) to observation.
Time frame: 3-year
Health-related cancer-specific quality of life
General quality of life and general cancer related symptoms is accessed by Quality of Life Core Questionnaire (QLQC-30), ,scored as quite a bit/very much vs no or mild symptoms
Time frame: 3-year,5-year
Incidence of Acute and lateToxicities
Acute radiation enteritis, radiation cystitis, radiation lymphopenia, late radiation enteritis, radiation cystitis, vaginal stenosis or shortening, lymphedema, bone marrow suppression according to CTCAE v 5.0.
Time frame: 3-year,5-year
Endometrial cancer related health care costs
All hospital based health care costs used with primary treatment or during follow-up for treatment of adverse events and/or treatment for relapse.
Time frame: 3 years, 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.