Could chemo after surgery beat endometrial cancer relapse?
NCT ID NCT01244789
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether giving chemotherapy after surgery can help people with early-stage (stage I-II) endometrial cancer who have a higher risk of the cancer coming back. About 244 patients will either receive six cycles of carboplatin and paclitaxel or simply be observed. The goal is to see if chemo improves overall survival compared to observation alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- carboplatin and paclitaxel (chemotherapy)
- What this could lead to
- If successful, this could show that chemotherapy after surgery helps more people with early-stage endometrial cancer live longer without the disease coming back.
- What could go wrong
- This is a phase 2 trial, so results are still uncertain. Chemotherapy can cause side effects like fatigue, nausea, and nerve damage, and it may not improve survival for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
244 people
The number who actually took part.
- Started
-
Dec 2011
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Target Population 1. 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: 1. Stage I grade 3 endometrioid adenocarcinoma 2. Stage II endometrioid adenocarcinoma 3. Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, or undifferentiated carcinoma) Prior therapy 2. Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy (LNE). 3. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional 4. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma. 5. 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 6. Patients must give informed consent according to the rules and regulations of the individual participating centres 7. Patients have not received any other anticancer therapy other than surgery. 8. Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery. 9. Patients must have a WHO performance status of 0-2 10. Patients must have an adequate bone-marrow, renal and hepatic function (WBC ≥3.0x109/L, neutrophils ≥1.5x109/L, platelets ≥100x109/L, total S-bilirubin \<2 x upper normal value, ALAT \<2.5 x upper normal value, estimated GFR \>50 ml/min (measured or calculated according to Cockroft-Gault or Jeliffe). Up to 5% deviation for hematological values and 10% deviation for s-bilirubin and ALAT are tolerated. 11. Life expectancy of at least 12 weeks 12. Patients must be fit to receive combination chemotherapy 13. Patient's age \>18 years Exclusion criteria: Target Disease Exceptions 1. Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation. Prohibited Treatments and/or Therapies 2. External Beam Radiotherapy 3. Concurrent cancer therapy 4. Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial Other exclusion criteria 5. Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin 6. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed 7. Whatever reasons which interferes with an adequate follow-up
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Danish Gynecological Cancer Group (DGCG)
Copenhagen, 2100, Denmark
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