A Phase 2 interventional study of carboplatin and paclitaxel and observation in Endometrial Cancer, sponsored by Danish Gynecological Cancer Group. Active, not recruiting at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Danish Gynecological Cancer Group · Phase 2, Interventional, and Treatment
Patients with stage 1 \& 2 endometrial cancer are treated with surgery. Despite the fact that disease is confound to uterus, unfortunately some of these patients may relapse and die of their disease. Postoperative radiotherapy cannot improve survival. Chemotherapy has shown survival benefit in more advanced stage disease (stage 3 \& 4).
This study evaluates if one can improve survival in intermediate and high risk early-stage patients by offering them postoperative chemotherapy. This is a randomized phase 3 trial where effect of postoperative chemotherapy is compared with postoperative observation alone (standard strategy).
Substudy: Translational research
Patients with medium and high risk stage I and II endometrial cancers have, despite radical surgery, a rather high risk for progression.
Adjuvant radiotherapy was the traditional therapy for many decades. Four randomized phase III studies and a meta-analysis have revealed that adjuvant radiotherapy improves local control at the cost of excessive short and long term toxicity, though has absolutely no impact on survival.
Two phase III studies have randomized between adjuvant radiotherapy versus adjuvant chemotherapy, both failed to show any difference in survival between radiotherapy and chemotherapy, though both studies are criticized for inferior chemotherapy regimens or inclusion of good prognosis patients. The GOG-122 study on more advanced cases (stage 3 \& 4) randomized between combination chemotherapy versus whole abdominal irradiation and found significant improvement in survival in the chemotherapy arm.
NSGO-EC-9501 and MaNGO studies have indicated that adjuvant chemotherapy added to adjuvant radiotherapy may improve survival compared to adjuvant radiotherapy alone in early stage medium and high risk patients. One may conclude that impact on survival comes only from chemotherapy. Many investigators have therefore adapted adjuvant chemotherapy as standard treatment in various countries including Denmark. However, such conclusion has low level of evidence, as there are no randomized phase III studies comparing postoperative observation alone versus adjuvant chemotherapy.
It is of utmost importance to demonstrate efficacy of adjuvant combination chemotherapy in a randomized phase III trial comparing to no further treatment in the medium and high risk node negative stage 1 \& 2 patients.
Combination chemotherapy regimen of paclitaxel-carboplatin is proposed in this study, as this combination is effective and well tolerated.
The eligible patients for such a study are a fraction of patients with endometrial cancer therefore this study will be performed within the ENGOT collaboration.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 244 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →This is the only study on the registry with Danish Gynecological Cancer Group as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Target Population
Only node-negative patients are eligible: Histological confirmed endometrial carcinoma with no macroscopic remaining tumour after primary surgery and lymph-node negative disease, with one of the following postoperative FIGO 2009 stage and grade:
Surgery performed within 10 weeks of randomization. If the dates for hysterectomy and lymph node dissection are different, 10 weeks are counted from the last surgery, and in that case the gap between two surgeries should not exceed 8 weeks.
Other inclusion criteria
Exclusion criteria:
Target Disease Exceptions
Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation.
Prohibited Treatments and/or Therapies
postoperative observation only
Other: observation
postoperative 6 courses of 3 weekly iv carboplatin-paclitaxel combination chemotherapy
Drug: carboplatin and paclitaxel
6 courses of iv 3-weekly chemotherapy Carboplatin AUC5 Paclitaxel 175mg/m2
active observation
Overall survival
To detect an overall absolute difference in five-year survival of 10%, from 72% to 82%, at the 2.5% level with 80% power, 135 deaths corresponding to 644 patients are needed. Assuming a dropout rate of 5%, 678 patients have to be accrued, leaving 644 patients for the overall analysis.
Time frame: through study completion, an average of 1 year
Overall Survival in endometrioid subgroup
In the endometrioid subgroup an absolute difference in five-year survival of 12%, from 74% to 86% is expected. Assuming this, 79 deaths corresponding to 438 patients are needed to yield 80% power at the 2.5% level. Assuming a dropout rate of 5%, 678 patients have to be accrued, leaving 644 patients for the overall analysis and 75% of these, or 483 patients, for the analysis in the endometrioid subgroup.
Time frame: through study completion, an average of 1 year
Disease Specific Survival
Exploratory endpoint
Time frame: through study completion, an average of 1 year
Progression-Free Survival
Exploratory endpoint
Time frame: through study completion, an average of 1 year
Toxicity - Acute toxicity (0-6 months from randomization). Late toxicity is registered during whole study period.
Acute toxicity (0-6 months from randomization). Late toxicity is registered during whole study period. Exploratory endpoint
Time frame: through study duration, 13 years
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN30)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - (EORTC QLQ-C30)
Time frame: From enrollment to the end of treatment at 60 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24)
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire- Endometrial Cancer Module, 24
Time frame: From enrollment to the end of treatment at 60 months
Rate of isolated pelvic relapse
Exploratory endpoint
Time frame: through study completion, an average of 17 years
Rate of isolated distant relapse
Exploratory endpoint
Time frame: through study completion, an average of 17 years
Rate of mixed (local & distant) relapses
Exploratory endpoint
Time frame: through study completion, an average of 17 years
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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