Clinical trial · Interventional
Papillary Serous Carcinoma of the Endometrium
A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium
NCT00515073CI-TRIAL-00014998completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Primary Objectives: * To evaluate the results of Paclitaxel and pelvic radiation in pelvic confined papillary serous carcinoma of the endometrium for both local control and overall survival. * To evaluate the toxicity of Paclitaxel and pelvic radiation. * To collect and evaluate patients' quality of life/symptom assessment data.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cimetidine | Drug | — | UNRESOLVED |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Diphenhydramine | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pelvic Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel (Taxol) + Pelvic Radiation
- description
- Paclitaxel (Taxol) 50 mg/m\^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments. Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m\^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m\^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.
- interventionNames
- Drug: Paclitaxel
- Radiation: Pelvic Radiation
- Drug: Dexamethasone
- Drug: Cimetidine
- Drug: Diphenhydramine
Primary outcomes (1)
- measure
- Overall Survival at 2 Years and 5 Years
- timeFrame
- Assessment at 2 years and 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patient must undergo surgical staging within 8 weeks of study entry. 2. Patients with mixed histology tumor that include a papillary serous component are eligible. 3. Only patients with non-measurable disease can be entered. 4. Patients may not have had previous chemotherapy or radiation therapy. 5. Patients must have an estimated life expectancy of 12 weeks or greater. 6. Patients must have a Zubrod performance status of less than or equal to 2. 7. Patients must have adequate bone marrow, renal and hepatic function: with white blood count (WBC) greater than or equal to 3000; Absolute neutrophil count (ANC) greater than or equal to 1500; Platelets greater than or equal to 100,000; glutamic-pyruvic transaminase (SGPT) less than or equal to 2 times the upper limit of normal; Total bilirubin less than or equal to 2.5mg/dl. 8. Patients must sign an institutionally approved consent form Exclusion Criteria: 1. Previously treated papillary serous carcinoma with either chemotherapy or radiation therapy. 2. Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV (patients with disease outside the pelvis). 3. Patients who have a history of other malignancy, with the exception of non-melanomatous skin cancer, unless in complete remission and off all therapy for that disease for a minimum of 5 years. 4. Patients with a Zubrod status of 3 or greater. 5. Patients with an active infection. 6. Patients with serious intercurrent medical illness. 7. Patients with a recent (within 6 months) history of congestive heart failure, unstable angina or myocardial infarction.
References
Publications (1)
- RESULTJhingran A, Ramondetta LM, Bodurka DC, Slomovitz BM, Brown J, Levy LB, Garcia ME, Eifel PJ, Lu KH, Burke TW. A prospective phase II study of chemoradiation followed by adjuvant chemotherapy for FIGO stage I-IIIA (1988) uterine papillary serous carcinoma of the endometrium. Gynecol Oncol. 2013 May;129(2):304-9. doi: 10.1016/j.ygyno.2013.01.025. Epub 2013 Feb 4. PMID 23385150