Clinical trial · Interventional
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Endometrial Cancer
A Randomized Trial of Adjuvant Treatment With Radiation Plus Chemotherapy Versus Radiation Alone in High Risk Endometrial Carcinoma
- 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 tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating high-risk endometrial cancer. PURPOSE: This randomized phase III trial is studying radiation therapy and chemotherapy to see how well they work compared to radiation therapy alone in treating patients with high-risk 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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| epirubicin hydrochloride | Drug | Epirubicin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-free survival
- measure
- Relapse-free survival
Secondary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed endometrial cancer of 1 of the following types: * Clear cell carcinoma * Serous papillary carcinoma * Undifferentiated (anaplastic) carcinoma * Poorly differentiated (FIGO grade 3) adenocarcinoma with infiltration to more than half the myometrial thickness * No small cell carcinoma with neuroendocrine differentiation * Primary in FIGO surgical stage I or occult stage II * No spread of disease outside the uterine corpus except to pelvic lymph nodes * No spread of disease to para-aortic lymph nodes * Positive peritoneal washings allowed * No preoperative macroscopic tumor involvement of the cervix * Microscopic tumor involvement of the cervix on histopathological evaluation of the operative uterine specimen allowed PATIENT CHARACTERISTICS: Age: * Any age Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Adequate bone marrow function * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Adequate hepatic function Renal: * Adequate renal function * Creatinine no greater than 1.4 mg/dL Pulmonary: * Adequate pulmonary function Other: * Not pregnant or nursing * Fit to receive combination chemotherapy * No other malignancy except basal cell or squamous cell skin cancer * No uncontrolled or potentially active site of infection (e.g., fistula or abscesses) * No other concurrent condition that would produce a substantial increase in risk for complications from radiotherapy * No other concurrent condition that would interfere with adequate follow-up PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * No prior preoperative irradiation Surgery: * No prior extensive abdominal surgery
References
Publications (2)
- BACKGROUNDHogberg T, Signorelli M, de Oliveira CF, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. doi: 10.1016/j.ejca.2010.06.002. Epub 2010 Jul 7. PMID 20619634
- RESULTHogberg T, Rosenberg P, Kristensen G, et al.: A randomized phase-III study on adjuvant treatment with radiation (RT) ± chemotherapy (CT) in early-stage high-risk endometrial cancer (NSGO-EC-9501/EORTC 55991). [Abstract] J Clin Oncol 25 (Suppl 18): A-5503, 274s, 2007.