Clinical trial · Interventional
A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer
Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line and Maintenance Treatment in Serous or p53 Mutant Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
This is an umbrella, two-arm, multi-stage, phase II trial. The purpose of the trial in the early stage cohort is to determine if EBRT improves disease free survival (defined as the time from random assignment to disease recurrence or death from any cause) compared to vaginal brachytherapy after chemotherapy in women with serous or p53 aberrant endometrial cancer. The purpose of the trial in the advanced stage cohort is to determine if the maintenance with experimental treatment increases progression free survival, defined as the time from random assignment to disease progression or death from any cause.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Carcinoma | Endometrial Carcinoma | ONTOLOGY_EXACT | 0.98 |
| P53 Mutation | — | UNRESOLVED | — |
| Serous Carcinoma | Ovarian Serous Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiation | Radiation | — | UNRESOLVED |
| Niraparib | Drug | Niraparib | ALIAS |
| Observation - no drugs | Other | — | UNRESOLVED |
| Vaginal high-dose rate brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Early Stage Cohort - Arm A
- description
- Pelvic EBRT at 45Gy in 25 fractions, in 1.8Gy fractions daily, 5 days per week
- interventionNames
- Radiation: External Beam Radiation
- type
- EXPERIMENTAL
- label
- Early Stage Cohort - Arm B1
- description
- Vaginal high-dose rate brachytherapy 21 Gy in 3 fractions, prescribed to 5mm (i.e. 100% isodose at 5mm) from the cylinder/applicator surface and top along the upper third to half of the vagina (minimum 3cm, maximum 4cm).
- interventionNames
- Radiation: Vaginal high-dose rate brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- Advanced Stage Cohort Arm C
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pure serous endometrial carcinoma will be included. Other histotypes (endometrioid and clear cell) with abnormal/mutant-type p53 is acceptable. * Local TP53 results must be available for Central review. * Patients diagnosed with stage I, II tumors will be enrolled in the early stage cohort. * Patients suitable for an optimal surgery. * Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%). * Life expectancy of greater than 3 months. * Patients must have archival tissue available. If no tissue is available, tumor biopsy will be mandatory. * Ability to understand and willing to sign a written informed consent document. * Within 8 days of the proposed start of treatment, patients must have normal organ and marrow function. * Women of child-bearing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. Exclusion Criteria: * Any other condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * Mixed serous tumors without p53 aberration or with only subclonal p53 aberration * Endometrial carcinosarcoma * Patients being treated with radiotherapy within 4 weeks, or palliative radiotherapy encompassing \>20% of the bone marrow within 1 week of starting study treatment. * Patients who are receiving any other investigational agents. * Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted. * Patients with evidence of fistula will be excluded. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study. * Uncontrolled inter-current illness that would limit compliance with study requirements. * Pregnant women are excluded. * Known HIV-positive patients on antiretroviral therapy or active Hepatitis B or C are ineligible. * Patients with a history of other malignancy ≤ 2 years prior to registration, with exceptions.
References
Publications (0)
Data not yet available