Chemotherapy or Observation in Stage I-II Intermediate or High Risk Endometrial Cancer

NCT01244789 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: ENGOT-EN2-DGCG2010-023081-52
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Endometrial Cancer

Keywords

endometrial cancer; chemotherapy; carboplatin; paclitaxel; Stage 1 & 2; node-negative; intermediate risk; high risk

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Overall Survival in endometrioid subgroup

  through study completion, an average of 1 year

• Disease Specific Survival

  through study completion, an average of 1 year

• Progression-Free Survival

  through study completion, an average of 1 year

• Toxicity - Acute toxicity (0-6 months from randomization). Late toxicity is registered during whole study period.

  through study duration, 13 years

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN30)

  From enrollment to the end of treatment at 60 months

Study Arms (2)

Observation

ACTIVE COMPARATOR

postoperative observation only

Other: observation

Combination chemotherapy

EXPERIMENTAL

postoperative 6 courses of 3 weekly iv carboplatin-paclitaxel combination chemotherapy

Drug: carboplatin and paclitaxel

Interventions

carboplatin and paclitaxel DRUG

6 courses of iv 3-weekly chemotherapy Carboplatin AUC5 Paclitaxel 175mg/m2

Combination chemotherapy

observation OTHER

active observation

Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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.
• Patients must give informed consent according to the rules and regulations of the individual participating centres
• Patients have not received any other anticancer therapy other than surgery.
• Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing of VBT should not cause delay in chemotherapy delivery.
• Patients must have a WHO performance status of 0-2
• 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.
• Life expectancy of at least 12 weeks

You may not qualify if:

• Target Disease Exceptions
• Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation.
• Prohibited Treatments and/or Therapies
• External Beam Radiotherapy
• Concurrent cancer therapy
• 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

Sponsors & Collaborators

• North Eastern German Society of Gynaecological Oncology: collaborator
• Belgian Gynaecological Oncology Group: collaborator
• Mario Negri Gynecologic Oncology group (MaNGO): collaborator
• Israeli Society of Gynecologic Oncology: collaborator
• Central and Eastern European Oncology Group: collaborator
• Danish Gynecological Cancer Group: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• Arbeitsgemeinschaft Gynaekologische Onkologie Austria: collaborator
• Nordic Society of Gynaecological Oncology - Clinical Trials Unit: collaborator
• Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO): collaborator

Study Sites (1)

Danish Gynecological Cancer Group (DGCG)

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Carboplatin; Paclitaxel; Observation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Methods; Investigative Techniques

Study Officials

• Kristine Madsen, MD

  Danish Gynecological Cancer Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2010
• First Posted: November 19, 2010
• Study Start: December 1, 2011
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

DK (1)