Clinical trial · Interventional
Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery
A Pilot Safety and Toxicity Trial of Adjuvant Chemotherapy With Gemcitabine and Docetaxel and Radiation Therapy for Completely Resected Uterine Leiomyosarcoma
NCT01958580CI-TRIAL-00068854terminatedN/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): Study terminated due to low accrual. PI left the institution
Summary
Brief summary (as posted)
This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.
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 |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| External Beam Radiation Therapy | Radiation | — | UNRESOLVED |
| Gemcitabine Hydrochloride | Drug | Gemcitabine | ALIAS |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Internal Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
- description
- CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
- interventionNames
- Drug: Gemcitabine Hydrochloride
- Drug: Docetaxel
- Radiation: Internal Radiation Therapy
- Radiation: Intensity-Modulated Radiation Therapy
- Radiation: External Beam 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 2 years. The study was terminated prior to analyses
- description
- Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented uterine leiomyosarcoma with no visible residual disease * Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling * 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) * Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) * Patients with any prior chemotherapy or radiotherapy for pelvic malignancy * Patients who have had prior therapy with gemcitabine or docetaxel * Patients with known hypersensitivity to gemcitabine or docetaxel * Patients with known hypersensitivity to pegfilgrastim and filgrastim * 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.