Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
Phase I Trial of the Treatment of Advanced Endometrial Cancer With Concurrent Weekly Paclitaxel and Cisplatin and Whole Abdominal Radiation Therapy
- 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 phase I trial is studying the side effects and best dose of combination chemotherapy when given with radiation therapy in treating patients with stage III or stage IV endometrial cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
Conditions
Conditions (4)
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 Clear Cell Adenocarcinoma | Endometrial Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Serous Adenocarcinoma | Endometrial Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage III Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel, cisplatin, abdominal radiotherapy)
- description
- Patients receive paclitaxel IV over 1 hour and cisplatin IV on days 1, 8, 15, 22, 29, and 36. Patients also undergo whole abdominal radiotherapy for 5 consecutive days weekly for 6 weeks. Cohorts of 3-6 patients receive escalating doses of paclitaxel and cisplatin until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level.
- interventionNames
- Drug: Paclitaxel
- Drug: Cisplatin
- Radiation: Radiation Therapy
Primary outcomes (2)
- measure
- Acute toxicity for identification of MTD, using the 21 major categories of the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTEP CTC) v2.0
- timeFrame
- Up to 30 days post-radiotherapy
- description
- Calculated using a 90% conditional likelihood-based confidence bound.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed surgical stage III or IV endometrial cancer * Any stage clear or serous papillary endometrial cancer * Positive para-aortic lymph nodes allowed * Tumor must be surgically reduced to 2 cm or less within 8 weeks of study * Must have had hysterectomy and bilateral salpingo-oophorectomy * No recurrent disease * No metastases to lung or liver parenchyma or inguinal or scalene lymph nodes * Performance status - GOG 0-2 * Absolute neutrophil count greater than 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT no greater than 3 times ULN * Creatinine no greater than 1.5 times ULN * No other prior or concurrent malignancy in the past 5 years except non-melanoma skin cancer * No prior chemotherapy * No prior radiotherapy * See Disease Characteristics * No more than 8 weeks since prior surgery * No prior anticancer therapy that would preclude study
References
Publications (0)
Data not yet available