PROfiling Based Endometrial Cancer Adjuvant Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorWomen's Hospital School Of Medicine Zhejiang University
About this trial
This is a prospective, multicenter, randomized phase III trial among women with endometrioid adenocarcinoma with high-intermediate and intermediate risk features to investigate the role of integrated genomic-pathologic classification to determine if participants should receive no adjuvant therapy, vaginal brachytherapy, external beam radiotherapy or chemo-radiation therapy based on molecular features as compared to standard radiation therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Surgery consisting of a total abdominal or laparoscopic hysterectomy, bilateral salpingectomy, pelvic lymphadenectomy or sentinel lymph node mapping and dissection, with or without para-aortic lymphadenectomy, oophorectomy
World Health Organization (WHO)-performance status 0-2
Written informed consent
Disqualifiers
With residual disease
Any other stage and type of endometrial carcinoma
Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
Uterine sarcoma (including carcinosarcoma)
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal brachytherapy
RadiationInternal radiation of the vaginal vault using a vaginal cylinder. For brachytherapy administered alone it is recommended: suggested dose is either 3 fractions of 7 Gy or 5 fractions of 6 Gy. For brachytherapy administered after completion of External beam radiotherapy (EBRT): Total dose should aim to be 65 Gy, and suggested dose is 2-3 fractions of 5-6 Gy
External beam radiotherapy
RadiationExternal beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
Observation
Other interventionNo adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
Chemoradiation therapy
Combination product4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Treatment groups
590 Participants
are divided into 2 treatment groupsGroup A: Molecular profile based treatmentExperimental treatment 3 interventions
Group B: RadiotherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Total recurrence
Vaginal, pelvic or distant recurrence as first failure
Time frame
3 yearsSecondary outcomes
1
Relapse-free survival
Relapse-free survival (survival without relapse)
Time frame
3 years, 5 years2
Survival
Overall survival (all-cause death)
Time frame
3 years, 5 years3
Adverse events
Treatment-related symptoms according to CTCAE v 5.0
Time frame
3 years, 5 years4
Health-related cancer-specific quality of life
Quality of Life Core Questionnaire (QLQC-30) - clinically relevant changes on Quality of Life Core Questionnaire-30 functioning scales, general quality of life and general cancer symptoms, quite a bit/very much vs no or mild symptoms
Time frame
3 years, 5 yearsOther outcomes
1
Recurrence (vaginal and total) per risk profile
Vaginal, pelvic and distant relapse split by risk profile and compared between the 2 arms
Time frame
3 years, 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Tongji Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Obstetrics & Gynecology Hospital of Fudan University
Collaborator
Sun Yat-sen University
Collaborator
Peking University People's Hospital
Collaborator
Shanghai First Maternity and Infant Hospital
Collaborator
Xiangya Hospital of Central South University
Collaborator
Anhui Provincial Cancer Hospital
Collaborator
Ningbo Women & Children's Hospital
Collaborator
Ningbo No. 1 Hospital
Collaborator
Source ClinicalTrials.gov