Clinical trial · Interventional
Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium
- 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: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also make tumor cells more sensitive to cisplatin. Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Vaginal Brachytherapy | Radiation | — | UNRESOLVED |
| Whole Abdominal Radiation [WAR] Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Whole-Abdominal Radiation Therapy and Chemotherapy
- interventionNames
- Radiation: Vaginal Brachytherapy
- Drug: Cisplatin
- Radiation: Whole Abdominal Radiation [WAR] Therapy
Primary outcomes (2)
- measure
- Toxicity as assessed by GOG Common Toxicity Criteria
- timeFrame
- Study duration
- measure
- Recommended phase II dose of whole-abdominal radiotherapy
- timeFrame
- Study duration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of endometrial cancer, including any of the following cellular types: * Papillary serous carcinoma * Clear cell carcinoma * Adenocarcinoma * Stage III or IV disease * No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or supraclavicular nodes) * Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian tube and ovary, and resection of any palpable lymph nodes in the pelvis and para-aortic region (or surgical sampling of these nodal regions if no palpable nodes were present) within the past 6 weeks * Peritoneal washings must have been collected for cytological evaluation * Must have ≤ 1 cm residual disease after surgery PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * Life expectancy ≥ 6 months * WBC ≥ 3,000/mm\^3 * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine \< 2.0 mg/dL * Bilirubin \< 1.5 times upper limit of normal (ULN) * Lactate dehydrogenase \< 3 times ULN * Gamma glutamyl transferase \< 3 times ULN * SGPT and SGOT \< 3 times ULN * Alkaline phosphatase \< 3 times ULN * No other malignant tumor within the past 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy to the whole abdomen and/or pelvis/vagina * No systemic chemotherapy within the past 5 years
References
Publications (0)
Data not yet available