Clinical trial · Interventional
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
NCT01367301CI-TRIAL-00068910terminatedN/AResults 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): Lack of accrual. PI left the institution
Summary
Brief summary (as posted)
This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine 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 or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage IB Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage IC Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage IIA Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage IIB Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage IIIA Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
| Stage IIIB Uterine Sarcoma | Uterine Corpus Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| external beam radiation therapy | Radiation | — | UNRESOLVED |
| intensity-modulated 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, radiotherapy)
- description
- CHEMOTHERAPY (weeks 1-9, 14-22): 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 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.
- interventionNames
- Drug: paclitaxel
- Drug: carboplatin
- Radiation: external beam radiation therapy
- Radiation: brachytherapy
- Radiation: intensity-modulated radiation therapy
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Recurrence-free Survival
- timeFrame
- Date of entry to date of reappearance of disease, assessed at 1 year
- description
- One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented uterine carcinosarcoma with no visible residual disease * Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings * Patients must be entered no more than 12 weeks post operatively * 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/mm3 * Absolute neutrophil count (ANC) \< 1500/mm3 * 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 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 * Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
References
Publications (0)
Data not yet available
No reference posted for this study.