Health TrialsbyHealthPanel

PErsonalized TReatment for Endometrial Carcinoma

ConditionEndometrial Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-100
SponsorUniversity of Helsinki

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 100 years

WHO performance status 0 to 2

Stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma

Disqualifiers

Age <18 years or >100 years

WHO performance status >2

Uterine sarcoma

A history of malignancy within 5 years

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comparison of chemotherapy vs. chemoradiotherapy

    Other intervention

    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).

  • Comparison of VBT vs. WPRT

    Other intervention

    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).

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: p53 abn subtype and nonendometrioid carcinomasExperimental treatment 1 intervention
Group B: MMR-D molecular subgroupExperimental treatment 1 intervention
Group C: NSMP molecular subgroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cancer reappearance

Cumulative incidence of disease recurrence

Time frame
5 years

Secondary outcomes

1

Location of cancer reappearance

Vaginal, pelvic, and distant recurrence rates

Time frame
5 years
2

Overall survival

The time from surgery to death

Time frame
5 years
3

Recurrence-free survival

The time from surgery to cancer recurrence

Time frame
5 years
4

Adverse events

Adjuvant therapy-related adverse events

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Helsinki

Lead sponsor

Turku University Hospital

Collaborator

Tampere University Hospital

Collaborator

Kuopio University Hospital

Collaborator

Oulu University Hospital

Collaborator

Kymenlaakso Central Hospital Kotka Finland

Collaborator

Päijänne Tavastia Central Hospital

Collaborator

South Carelia Central Hospital

Collaborator

Source ClinicalTrials.gov
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