To hear about similar clinical trials, please enter your email below
Trial Title:
Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions
NCT ID:
NCT05524389
Condition:
Endometrial Cancer
Adjuvant Radiotherapy
Molecular Classification
Conditions: Official terms:
Endometrial Neoplasms
Conditions: Keywords:
Endometrial Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Vaginal brachytherapy
Description:
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.
Arm group label:
Conventional risk stratification based treatment
Arm group label:
Molecular classification based treatment
Other name:
VBT
Intervention type:
Radiation
Intervention name:
Pelvic external beam radiotherapy
Description:
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
Arm group label:
Conventional risk stratification based treatment
Arm group label:
Molecular classification based treatment
Other name:
Pelvic EBRT
Intervention type:
Other
Intervention name:
Observation
Description:
No radiotherapy is administrated, but active follow-up and quality of life questionnaires
is needed after surgery.
Arm group label:
Molecular classification based treatment
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Intravenous concurrent or sequential adjuvant chemotherapy consists of
carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.
Arm group label:
Conventional risk stratification based treatment
Arm group label:
Molecular classification based treatment
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women aged 18-75.
2. Patients with newly histologically confirmed Endometrioid adenocarcinoma.
3. ECOG score 0-2
4. Surgery consisting of a total hysterectomy and bilateral salpingo-oophorectomy,
pelvic lymphadenectomy or sentinel lymph node biopsy, with or without para-aortic
lymphadenectomy, oophorectomy
5. Patients with FIGO staging(2009 edition) I or II and meet one of the following
conditions:
1. Stage IA G1-2 with massive LVSI+ or age ≥ 60 years
2. Stage IA G3, regardless of LVSI status
3. Stage IB G1-3, regardless of LVSI status
4. Stage II, regardless of tumor grade and LVSI status
6. Patients can understand the study protocol and voluntarily participate in the study,
and give written informed consent before treatment.
Exclusion Criteria:
1. Not FIGO stage I-II.
2. Residual tumor or positive margin.
3. Mixed carcinoma, sarcoma or carcinosarcoma
4. Previous history of malignant tumor
5. Previous history of pelvic radiotherapy
6. The interval between surgery and radiotherapy is more than 12 weeks.
7. With serious medical complications, such as heart disease, lung disease and other
diseases that cannot tolerate the whole course of radiotherapy
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 1, 2022
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Collaborator:
Agency:
Xijing Hospital, Air Force Medical University of PLA
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Dalian Medical University
Agency class:
Other
Collaborator:
Agency:
The second hospital Affiliated by Jilin University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Inner Mongolia Medical University
Agency class:
Other
Collaborator:
Agency:
Third Affiliated Hospital of Xinjiang Medical University
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
The 940th Hospital of Joint Logistics Support Force，PLA.
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524389
