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PErsonalized TReatment for Endometrial Carcinoma

NCT05655260 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-12-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy of adjuvant therapies in women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. Specifically, the invesigators want to compare:

* Chemotherapy vs. chemoradiotherapy in p53 abn subtype and nonendometrioid carcinomas.
* Vaginal brachytherapy vs. whole pelvic radiotherapy in the MMR-D molecular subgroup.
* Vaginal brachytherapy vs. whole pelvic radiotherapy in the NSMP molecular subgroup.

Conditions

  • Endometrial Adenocarcinoma

Interventions

OTHER

Comparison of chemotherapy vs. chemoradiotherapy

Chemotherapy (paclitaxel-carboplatin) vs. chemoradiotherapy (paclitaxel-carboplatin followed by whole pelvic radiotherapy) Patients assigned to chemotherapy receive paclitaxel (175 mg/m2) and carboplatin (area under curve, 5) every 3 weeks for 6 cycles. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).

OTHER

Comparison of VBT vs. WPRT

Vaginal brachytherapy vs. whole pelvic radiotherapy Patients randomized to vaginal brachytherapy receive cuff brachytherapy at 21 Gy in 3 fractions of 7 Gy at 0.5 cm depth. The pelvic radiotherapy dose is 45 to 50.4 Gy over 5 to 6 weeks (1.8 Gy per day for 25 to 28 fractions).

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Tampere University Hospital

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • Oulu University Hospital

    collaborator OTHER

  • Kymenlaakso Central Hospital Kotka Finland

    collaborator OTHER

  • Päijänne Tavastia Central Hospital

    collaborator OTHER

  • South Carelia Central Hospital

    collaborator OTHER

  • University of Helsinki

    lead OTHER

Principal Investigators

  • Mikko Loukovaara · Helsinki University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05655260 on ClinicalTrials.gov