Clinical trial · Interventional
Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma and Uterine Sarcoma, Clinical Stage I, IIA, Grade I, II, III
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus. Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Stage II Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage I Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Surgery | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo vaginal hysterectomy and BSO via laparoscopy.
- interventionNames
- Procedure: Laparoscopic Surgery
- Other: Quality-of-Life Assessment
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.
- interventionNames
- Other: Quality-of-Life Assessment
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (5)
- measure
- Duration of disease-free interval
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma * Must be considered a candidate for surgery * No contraindication to laparoscopy * No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix * Performance status - GOG 0-3 * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times normal * SGOT no greater than 3 times normal * Creatinine no greater than 2.0 mg/dL * Prior malignancy allowed if no current evidence of disease * Not pregnant * No prior pelvic or abdominal radiotherapy * See Disease Characteristics * No prior retroperitoneal surgery
References
Publications (1)
- DERIVEDBishop EA, Java JJ, Moore KN, Spirtos NM, Pearl ML, Zivanovic O, Kushner DM, Backes F, Hamilton CA, Geller MA, Hurteau J, Mathews C, Wenham RM, Ramirez PT, Zweizig S, Walker JL. Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study. Am J Obstet Gynecol. 2018 Jan;218(1):109.e1-109.e11. doi: 10.1016/j.ajog.2017.09.026. Epub 2017 Oct 14. PMID 29037481