Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNational Institute of Cancerología

About this trial

The purpose of this phase III clinical trial, is to evaluate the efficacy and safety of concomitant chemo-radiotherapy with Cisplatin vs Gemcitabine as the first line of treatment in patients with locally advanced cervical cancer, with comorbidities and preserved renal function.

Eligibility criteria

Qualifiers

Singed informed consent.

Women with Age ≥ 18 years.

-In women of childbearing age it should be documented: a) negative pregnancy test in serum at the beginning of the study (14 days before the start of QT-RT); b) Accept the use of some method of contraception approved by your attending physician during the study and 12 weeks after the treatment has ended.

-In postmenopausal women (surgical or natural menopause) at least one of the following parameters must be met for inclusion.

Disqualifiers

Patients with a second neoplasm.

Pregnant or lactating patients.

Patients with small cell and / or neuroendocrine CaCu.

Patients with impaired renal function with a GFR <or equal to 60ml / min calculated by the CKD-EPI formula

Trial design

Treatments tested in this trial

  • Gemcitabine
  • Cisplatin

Treatment groups

140 Participants
are divided into 2 treatment groups