An interventional study of Comparison of chemotherapy vs. chemoradiotherapy and Comparison of VBT vs. WPRT in Endometrial Adenocarcinoma, sponsored by University of Helsinki. Recruiting at 1 site in Finland. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by University of Helsinki · Not applicable, Interventional, and Treatment
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:
Endometrial carcinomas can be classified into four molecular subgroups, i.e. mismatch repair deficient (MMR-D), p53 abnormal (p53 abn), polymerase-ϵ (POLE) ultramutated, and "no specific molecular profile" (NSMP). Molecular subgroups can be considered to be distinct diseases as they are associated with different clinicopathologic characteristics, prognoses and, possibly, responses to adjuvant therapy. Molecular classification of endometrial carcinoma is recommended to be implemented in routine clinical practice to improve prognostication and triage to adjuvant therapy. The PErsonalized TReatment for Endometrial Carcinoma (PETREC) trial, led by the Finnish Gynecologic Oncology Group (FINGOG), is a multicenter prospective clinical trial for women with stage I-II molecular integrated high-intermediate or high-risk endometrial carcinoma. The efficacy of chemotherapy vs. chemoradiotherapy is compared in p53 abn subtype and nonendometrioid carcinomas, and vaginal brachytherapy vs. whole pelvic radiotherapy in MMR-D and NSMP molecular subgroups. Patients who consent to follow-up within the trial but not to randomization are treated as recommended in multidisciplinary meetings and enrolled for follow-up only (comprehensive cohort study design). The primary outcome is the 5-year cumulative incidence of disease recurrence. Secondary outcomes are vaginal, pelvic, and distant recurrence rates, 5-year recurrence-free and overall survival, adverse events, and patient-reported symptoms and quality of life. The findings of the trial may eventually help decrease under- and overtreatment and, consequently, improve patient outcome and decrease treatment-associated adverse effects.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 300 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of Helsinki is the lead sponsor of 129 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
p53 abn stage I-II MI (myometrial invasion) \>0%; MMR-D/NSMP nonendometrioid stage I-II MI \>0%
Other: Comparison of chemotherapy vs. chemoradiotherapy
MMR-D stage IA-B grade 1-2, substantial LVSI; MMR-D stage IA grade 3, substantial LVSI; MMR-D stage IB grade 3; MMR-D stage II grade 1-3;
Other: Comparison of VBT vs. WPRT
NSMP stage IA-B grade 1-2, substantial LVSI; NSMP stage IA grade 3, substantial LVSI; NSMP stage IB grade 3; NSMP stage II grade 1-3;
Other: Comparison of VBT vs. WPRT
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).
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).
Cancer reappearance
Cumulative incidence of disease recurrence
Time frame: 5 years
Location of cancer reappearance
Vaginal, pelvic, and distant recurrence rates
Time frame: 5 years
Overall survival
The time from surgery to death
Time frame: 5 years
Recurrence-free survival
The time from surgery to cancer recurrence
Time frame: 5 years
Adverse events
Adjuvant therapy-related adverse events
Time frame: 5 years
Plan to share: No
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University of Helsinki