Adjuvant Radiotherapy, Endometrial Cancer, Molecular Classification
Conditions
Keywords
Endometrial Cancer
Brief 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.
Interventions
RADIATIONVaginal brachytherapy
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.
RADIATIONPelvic external beam radiotherapy
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
OTHERObservation
No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.
DRUGChemotherapy
Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.
Sponsors
The First Affiliated Hospital of Air Force Medicial University
The Second Affiliated Hospital of Dalian Medical University
Second Hospital of Jilin University
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Inner Mongolia Medical University
Third Affiliated Hospital of Xinjiang Medical University
Peking University First Hospital
940 Hospital of the People's Liberation Army Joint Logistic Support Force
Xiangya Hospital of Central South University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Loco-regional recurrence (LRR) | 3-year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survical(OS) | 3-year,5-year | Overall survival is calculated from randomization to death from any cause. |
| Cumulative vaginal recurrence | 3-year,5-year | Recurrence in the vaginal area during follow-up |
| Cumulative pelvic recurrence | 3-year,5-year | Recurrence in the pelvic area, including the vagina, during follow-up |
| Distance metastasis(DM) | 3-year,5-year | Distant metastasis (such as bone, lung, liver, brain, non-pelvic regional lymph node metastasis). |
| Failure free survival(FFS) | 3-year,5-year | FFS is defined as the time from randomization to recurrence,distant metastasis or death from any cause,whichever is first. |
| Health-related cancer-specific quality of life | 3-year,5-year | 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 |
| Incidence of Acute and lateToxicities | 3-year,5-year | 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. |
| Endometrial cancer related health care costs | 3 years, 5 years | All hospital based health care costs used with primary treatment or during follow-up for treatment of adverse events and/or treatment for relapse. |
| De-escalation rate of treatment | 3-year | 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. |
Contacts
Primary ContactXiaorong Hou, PhD
Backup ContactXiaorong Hou, PhD
Outcome results
None listed