Clinical trial NCT05524389: Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions
Official title: A Prospective Multicentre Phase III Randomised Open Clinical Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Endometrial Cancer
Adjuvant Radiotherapy
Molecular Classification
Keywords: Endometrial Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Air Force Medicial University
name: The Second Affiliated Hospital of Dalian Medical University
name: The second hospital Affiliated by Jilin University
name: First Affiliated Hospital Xi'an Jiaotong University
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Third Affiliated Hospital of Xinjiang Medical University
name: Peking University First Hospital
name: 940 Hospital of the People's Liberation Army Joint Logistic Support Force
name: Xiangya Hospital of Central South University
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2022-09-01
Enrollment: 624
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Loco-regional recurrence (LRR)
timeFrame: 3-year
Secondary outcomes:
measure: Failure free survival(FFS)
timeFrame: 3-year,5-year
measure: Overall survical(OS)
timeFrame: 3-year,5-year
measure: Cumulative vaginal recurrence
timeFrame: 3-year,5-year
measure: Cumulative pelvic recurrence
timeFrame: 3-year,5-year
measure: Distance metastasis(DM)
timeFrame: 3-year,5-year
measure: De-escalation rate of treatment
timeFrame: 3-year
measure: Health-related cancer-specific quality of life
timeFrame: 3-year,5-year
measure: Incidence of Acute and lateToxicities
timeFrame: 3-year,5-year
measure: Endometrial cancer related health care costs
timeFrame: 3 years, 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Ren K, Wang W, Sun S, Hou X, Hu K, Zhang F. Recurrent patterns after postoperative radiotherapy for early stage endometrial cancer: A competing risk analysis model. Cancer Med. 2022 Jan;11(1):257-267. doi: 10.1002/cam4.4423. Epub 2021 Nov 15.