Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer (NCT01244789) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer
Denmark244 participantsStarted 2011-12
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Stage I grade 3 endometrioid adenocarcinoma
. Stage II endometrioid adenocarcinoma
. Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, or undifferentiated carcinoma) Prior therapy
. Patients have undergone hysterectomy (total abdominal hysterectomy, radical hysterectomy, laparoscopic or robotic hysterectomy) and bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy (LNE).
. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is optional
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is no longer enrolling — does that mean there are already some early results about overall survival that my doctor could review to help us understand whether chemotherapy or observation might be a better path for my stage of endometrial cancer?
2Since this trial compares chemotherapy against observation for intermediate or high-risk Stage I-II endometrial cancer, can my doctor explain how my specific risk classification was determined and which arm of this study would most closely match the treatment approach they'd recommend for me?
3Because this is a Phase 2 trial, the safety and benefit data are still more limited than a larger Phase 3 study — what does my doctor think is currently known about the risks of chemotherapy compared to watchful waiting for someone at my risk level?
4Given that the trial is active but no longer recruiting, is there any way my doctor can access the emerging data or connect with the research team to inform my treatment decision, even if I can't formally enroll?
5Would my doctor recommend I pursue standard-of-care treatment first, and how does that compare to what this trial was testing for intermediate or high-risk Stage I-II endometrial cancer?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall survival
Timeframe: through study completion, an average of 1 year
. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma.
. 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.
Exclusion criteria
. Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation.
. External Beam Radiotherapy
. Concurrent cancer therapy
. Concurrent treatment with an anticancer investigational agent or participation in another anticancer clinical trial Other exclusion criteria
. Previous or concurrent malignant disease except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed
. Whatever reasons which interferes with an adequate follow-up