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Testing the Addition of Paclitaxel and Carboplatin Given After Standard Chemotherapy and Radiation for Cervical Cancer in HIV-positive Women

NCT03834571 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-06-21

No results posted yet for this study

Summary

This phase II trial studies how well standard chemotherapy and radiation therapy given with or without paclitaxel and carboplatin work in treating human immunodeficiency virus (HIV)-positive women with cervical cancer that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin work in different ways to stop the growth of tumor cells. They may either kill the cancer cells by stopping them from dividing, or by stopping them from spreading. Radiation therapy to the pelvis destroys potential cancer cells in the pelvic area and significantly reduces the risk of tumor recurrence in the pelvic area. It is not yet known if giving chemotherapy and radiation therapy with paclitaxel and carboplatin afterward may work better than than just chemotherapy and radiation therapy in treating HIV-positive patients with advanced cervical cancer.

Conditions

  • Cervical Adenocarcinoma
  • Cervical Adenosquamous Carcinoma
  • Cervical Squamous Cell Carcinoma, Not Otherwise Specified
  • FIGO Stage IIB Cervix Carcinoma
  • FIGO Stage III Cervix Carcinoma
  • FIGO Stage IVA Cervix Carcinoma
  • HIV Infection

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Paclitaxel

Given IV

PROCEDURE

Patient Monitoring

Undergo active monitoring

RADIATION

Radiation Therapy

Undergo radiation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • University of Stellenbosch

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • AIDS Malignancy Consortium

    lead NETWORK

Principal Investigators

  • Ntokozo Ndlovu · Parirenyatwa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2025-01-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • South Africa
  • Zimbabwe

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 NCT03834571 on ClinicalTrials.gov