Study of Early Stage Endometrial Cancer Based on Molecular Classification and Traditional Risk Stratification to Guide Adjuvant Radiotherapy Decisions

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05524389
• Other study ID #: ECMC-GART
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: August 2022
• Source: Peking Union Medical College Hospital
• Contact: Xiaorong Hou, PhD
• Phone: +86-13811963013
• Email: hxr_pumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 624
• Est. completion date: June 30, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjuvant Radiotherapy
• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• Vaginal 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.
• Pelvic 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

Other:
• Observation
No radiotherapy is administrated, but active follow-up and quality of life questionnaires is needed after surgery.

Drug:
• Chemotherapy
Intravenous concurrent or sequential adjuvant chemotherapy consists of carboplatin/paclitaxel, cisplatin/doxorubicin or cisplatin/doxorubicin/paclitaxel, etc.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital Xi'an Jiaotong University, Peking University First Hospital, The 940th Hospital of Joint Logistics Support Force,PLA., The Affiliated Hospital of Inner Mongolia Medical University, The Second Affiliated Hospital of Dalian Medical University, The second hospital Affiliated by Jilin University, Third Affiliated Hospital of Xinjiang Medical University, Xiangya Hospital of Central South University, Xijing Hospital, Air Force Medical University of PLA

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-year
Secondary	Failure free survival(FFS)	FFS is defined as the time from randomization to recurrence,distant metastasis or death from any cause,whichever is first.	3-year,5-year
Secondary	Overall survical(OS)	Overall survival is calculated from randomization to death from any cause.	3-year,5-year
Secondary	Cumulative vaginal recurrence	Recurrence in the vaginal area during follow-up	3-year,5-year
Secondary	Cumulative pelvic recurrence	Recurrence in the pelvic area, including the vagina, during follow-up	3-year,5-year
Secondary	Distance metastasis(DM)	Distant metastasis (such as bone, lung, liver, brain, non-pelvic regional lymph node metastasis).	3-year,5-year
Secondary	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.	3-year
Secondary	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	3-year,5-year
Secondary	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.	3-year,5-year
Secondary	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.	3 years, 5 years