Clinical trial · Interventional
Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
NCT00002807CI-TRIAL-00044492completedN/AClinicalTrials.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: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Observation
- type
- EXPERIMENTAL
- label
- Radiation
- description
- Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
- interventionNames
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Survival (combined with the ASTEC trial)
- timeFrame
- 2009
Secondary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium * Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy * Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades) * Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible * Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible * No pathologically involved lymph nodes if staging procedure performed * Stage I papillary serous or clear cell endometrial cancer allowed PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * ECOG 0-3 Life expectancy: * At least 3 years Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Not specified Renal: * Creatinine less than 2 times upper limit of normal * No serious renal disease that would preclude radiotherapy Cardiovascular: * No serious cardiovascular disease that would preclude radiotherapy Other: * No history of inflammatory bowel disease such as ulcerative colitis * No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, colon cancer, or thyroid cancer * No psychiatric or addictive disorder that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior anticancer hormonal therapy * No concurrent progestogens Radiotherapy: * No prior pelvic irradiation * No prior or other concurrent vaginal intracavitary radiotherapy Surgery: * See Disease Characteristics Other: * No prior anticancer therapy * No other concurrent anticancer therapy
References
Publications (1)
- RESULTASTEC/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