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Papillary Serous Carcinoma of the Endometrium

NCT00515073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-07-03

Study results available
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Summary

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

Interventions

DRUG

Paclitaxel

50 mg/m\^2 IV over one hour on Day 1, 8, 15, 22, and 29 during radiation therapy followed by 4 additional courses at 135 mg/m\^2 IV over 3 hours every 21 days, 4-6 weeks after pelvic radiation is completed.

RADIATION

Pelvic Radiation

Radiation therapy to the pelvis daily for 25 treatments. Beginning Day 1 or 2 and given for 5 days for 5 weeks, giving a total dose of 45 Gy with external beam radiation to the pelvis. The vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for an additional 3 days depending on patient preference. No chemotherapy given with vaginal apex boost.

DRUG

Dexamethasone

20 mg IV given 30 minutes prior to chemotherapy

DRUG

Cimetidine

300 mg IV given 30 minutes prior to chemotherapy

DRUG

Diphenhydramine

50 mg IV given 30 minutes prior to chemotherapy

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Anuja Jhingran, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515073 on ClinicalTrials.gov