Medicines Control Authority of Zimbabwe

Public Clinical Trials Registry

List Applications   Download PDF

CT199/2020

NCT 03834571
09-07-2019

AMC 102

A Randomized Phase II Trial of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Paclitaxel and Carboplatin in HIV-Positive Women with Locally Advanced Cervical Cancer (LACC) (Version 3.0 09JUL2019)

Primary Sponsor Details
University of California, Los Angeles (ICLA) (USA)

Secondary Sponsor Details
Ivy Gudza
Coordinator
gudza.ivy@gmail.com
0775552955
Department of Medicine University of Zimbabwe College o
University of Zimbabwe College of Health Sciences
Dr Ntokozo Ndlovu
Principal Investigator
ntokozosqo@gmail.com
+263712200140
University Of Zimbabwe Clinical Research Centre. No2 Al
Department of Radiology University Of Zimbabwe College

Zimbabwe

South Africa
National Cancer institute (USA)
Women who are HIV-positive with incident locally-advanced cancer of the cervix (LACC).
I. CISPLATIN INJECTION II. PACLITAXEL INJECTION-USP 6mg/Ml III. CARBOPLATIN INJECTION BP 10mg/Ml IV. RADIATION THERAPY
Cisplatin 10mg 2880 vials for 60 participants, Carboplatin 500mg 120 vials for 30 participants, Paclitaxel 300mg 120 vials for 30 participants

Inclusion Criteria

  • Participants with locally advanced primary, untreated, histologically-confirmed, documented invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
  • HIV-1 infection
  • All patients must be prescribed combination antiretroviral therapy
  • Ability to understand and the willingness to provide informed consent to participate.
  • Karnofsky performance status of > 60%.
  • A negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception, highly effective hormonal contraception).
  • Participants should be suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiation.
  • Life expectancy of greater than 6 months.

 
  • Participants who do not fulfill the above criteria
  • Participants who have undergone hysterectomy.
  • Acute active (such as tuberculosis or malaria), serious, uncontrolled infection.

 

 

The primary endpoint, two-year progression-free survival (PFS), will be defined as the length of time from registration enrollment to disease recurrence, disease progression, or death for any reason. Participants who are alive and who did not experience disease recurrence or progression by the end of the study will be censored for PFS at the date of their last contact. The intervention arm will be compared to the control arm for improvement in PFS via one-sided log-rank test. This test will be conducted once for the interim analysis and once for the final analysis. The primary analysis on the primary efficacy endpoint will use the intention-totreat population. Additionally, the analysis on the primary efficacy endpoint will be performed using the per protocol population
9.0 DESIGN OF THE TRIAL
Opened

If controlled
Yes
No
No
No
No
Yes
All participants will receive Cisplatin and Chemoradiation for 6-8 weeks. After completion randomisation will be done. Half will receive adjuvant Carboplatin and the other half will be observaved as is the stand of care.
No
No
No
Yes
60
60
120
5 years (3 years of recruitment and 2 year of follow-up)