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Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer

NCT02112552 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-08-29

Study results available
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Summary

This pilot, phase II trial studies the side effects and how well paclitaxel given into the vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer. 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, stopping them from dividing, or stopping them from spreading. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed by radiation therapy may be an effective treatment for uterine cancer.

Conditions

  • Endometrial Serous Adenocarcinoma
  • Stage IIIA Uterine Corpus Cancer
  • Stage IIIB Uterine Corpus Cancer
  • Stage IIIC1 Uterine Corpus Cancer
  • Stage IIIC2 Uterine Corpus Cancer
  • Stage IVA Uterine Corpus Cancer
  • Stage IVB Uterine Corpus Cancer

Interventions

DRUG

Paclitaxel

Given IV

DRUG

Carboplatin

Given IP

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D conformal radiation therapy

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Marina Frimer, MD · Albert Einstein College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-10
Primary Completion
2016-08-31
Completion
2017-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02112552 on ClinicalTrials.gov