Clinical trial
Randomized Phase III Trial of Molecular Profile-based Versus Standard Recommendations for Adjuvant Therapy for Women With Early Stage Endometrioid Adenocarcinoma
Name
IRB-20210340-R
Description
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.
Trial arms
Trial start
2022-01-24
Estimated PCD
2024-12-31
Trial end
2027-01-01
Status
Recruiting
Treatment
Vaginal brachytherapy
Internal 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
Arms:
Molecular profile based treatment, Radiotherapy
External beam radiotherapy
External beam pelvic radiotherapy on a linear accelerator, 45-50 Gy in 25-28 out-patients sessions
Arms:
Radiotherapy
Observation
No adjuvant therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
Arms:
Molecular profile based treatment
Chemoradiation therapy
4 adjuvant cycles carboplatin and paclitaxel followed by External beam pelvic radiotherapy (45-50 Gy )
Arms:
Molecular profile based treatment
Size
590
Primary endpoint
Total recurrence
3 years
Eligibility criteria
Inclusion Criteria:
1. 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
2. Histologically confirmed endometrioid type endometrial carcinoma, International Federation of Gynecology and Obstetrics (FIGO) 2009 stage I, with one of the following combinations of stage and grade:
Stage I A, grade 3 Stage I B, grade 1 or 2 Stage I B, grade 3 Stage II
3. World Health Organization (WHO)-performance status 0-2
4. Written informed consent
Exclusion Criteria:
1. With residual disease
2. Any other stage and type of endometrial carcinoma
3. Histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma
4. Uterine sarcoma (including carcinosarcoma)
5. Previous malignancy (except for non-melanomatous skin cancer)
6. Previous pelvic radiotherapy
7. Expected interval between the operation and start of radiotherapy exceeding 8 weeks
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 590, 'type': 'ESTIMATED'}}
Updated at
2023-12-12
1 organization
1 product
2 indications
Product
Chemoradiation therapyIndication
Endometrial Cancer Stage IIndication
Endometrial Cancer Stage II