Clinical trial · Interventional
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging
NCT01041027CI-TRIAL-00070810terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to slow accrual. Results from the PORTEC3 the study rendered the hypothesis no longer valid.
Summary
Brief summary (as posted)
This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Giving radiation therapy with chemotherapy may kill more tumor cells.
Conditions
Conditions (9)
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 Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Stage IA Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Uterine Corpus Cancer | Malignant Uterine Corpus Neoplasm |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel, carboplatin, radiation therapy)
- description
- CHEMOTHERAPY (weeks 1-9, 13-21): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
- Radiation: Internal Radiation Therapy
- Radiation: External Beam Radiation Therapy
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-documented high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria: * Surgical stage I disease with \< 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement; * Surgical stage I disease with \>= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3); * Any surgical stage II disease (II); * Any surgical stage III disease (IIIA, IIIB, IIIC); and * Any surgical stage IV disease with no residual macroscopic tumor * Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria * Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 * Written voluntary informed consent Exclusion Criteria: * Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal * Total serum bilirubin \> 1.5 mg/dl * History of chronic or active hepatitis * Serum creatinine \> 2.0 mg/dl * Platelets \< 100,000/mm\^3 * Absolute neutrophil count (ANC) \< 1500/mm\^3 * Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry) * Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) * Patient with any prior chemotherapy or radiotherapy for pelvic malignancy * Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry * Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
References
Publications (0)
Data not yet available
No reference posted for this study.