Clinical trial · Interventional
Surgery With or Without Lymphadenectomy and Radiation Therapy in Treating Patients With Endometrial Cancer
A Randomised Trial of Lymphadenectomy and of Adjuvant External Beam Radiotherapy in the Treatment of Endometrial Cancer
NCT00003749CI-TRIAL-00013125completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Lymphadenectomy may remove cancer cells that have spread to nearby lymph nodes. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether conventional surgery is more effective with or without lymphadenectomy and/or radiation therapy in treating endometrial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of conventional surgery with or without lymphadenectomy and/or radiation therapy in treating patients who have endometrial cancer.
Conditions
Conditions (1)
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 Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| brachytherapy | Radiation | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: Surgical randomization: * Histologically confirmed endometrial carcinoma * Disease thought preoperatively to be confined to the uterine corpus Radiotherapy randomization: * Must have disease determined postoperatively to be confined to the uterine corpus, irrespective of pelvic node status * No cervical stroma invasion (stage IIB) * Must be macroscopically free of disease (no positive para-aortic nodes) * Must have high-risk disease defined as one or more of the following: * Grade 3 (poorly differentiated) * Invasion to the outer half of the myometrium (stage IC) * Serous papillary or clear cell type * Stage IIA (endocervical glandular involvement) PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other prior or concurrent malignancy likely to interfere with protocol treatment or comparisons * Surgical randomization: * Must be fit to undergo lymphadenectomy and external beam radiotherapy * Radiotherapy randomizations: * Must be fit to receive external beam radiotherapy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (4)
- BACKGROUNDASTEC/EN.5 Study Group; Blake P, Swart AM, Orton J, Kitchener H, Whelan T, Lukka H, Eisenhauer E, Bacon M, Tu D, Parmar MK, Amos C, Murray C, Qian W. Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN.5 randomised trials): pooled trial results, systematic review, and meta-analysis. Lancet. 2009 Jan 10;373(9658):137-46. doi: 10.1016/S0140-6736(08)61767-5. Epub 2008 Dec 16. PMID 19070891
- RESULTKitchener HC: The effect of incision in the surgical treatment of endometrial cancer and long-term follow-up of a randomized trial of lymphadenectomy: results of the MRC ASTEC trial. [Abstract] J Clin Oncol 29 (Suppl 15): A-e15583, 2011.
- RESULTASTEC study group; Kitchener H, Swart AM, Qian Q, Amos C, Parmar MK. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet. 2009 Jan 10;373(9658):125-36. doi: 10.1016/S0140-6736(08)61766-3. Epub 2008 Dec 16. PMID 19070889
- RESULTBarton DP, Naik R, Herod J. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC Trial): a randomized study. Int J Gynecol Cancer. 2009 Nov;19(8):1465. doi: 10.1111/IGC.0b013e3181b89f95. No abstract available. PMID 19893425