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MICHELENCT06156514

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints: details revised at 2 of 6 entriesv4
  2. Secondary endpoints: details revised at 2 of 6 entriesv3
  3. Secondary endpoints: 5 to 6v2
  4. Study First Submitted
  • Minor: routine updates

Endpoints

Primary

To assess the efficacy of concomitant chemoradiotherapy with gemcitabine versus cisplatin in patients with locally advanced cervical cancer (stages IB2-IVA), who have comorbidities and preserved renal function, with progression-free survival rate.
Timeframe: 3 year

Secondary (6)

To determine the objective response rate after the treatment of concomitant QT-RT with Gemcitabine vs cisplatin in patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function.
Incidence of Treatment-Emergent Adverse Events of concomitant QT-RT with gemcitabine vs cisplatin in patients with locally advanced cervical cancer with stages IB2-IVA with comorbidities and preserved renal function.
Determine the Overall Response Rate (ORR) defined as the percentage of people in the study with partial or complete response to treatment in a given period of time, assessed by RECIST v1.1 and PERCIST criteria.
Document the prevalence of comorbidities in this group of patients
To evaluate the quality of life of patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function with the EORTC QLQ-30.
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To evaluate the quality of life of patients with locally advanced cervical cancer with stages IB2-IVA, with comorbidities and preserved renal function with the EORTC QLQ CX-24 questionnaires.

Arms and interventions

A (Gemcitanine)Experimental

To receive concomitant chemotherapy based on gemcitabine at 300 mg / m2 weekly

B (Cisplatin)Active comparator

To receive concomitant chemotherapy based on cisplatin 40 mg / m2 weekly

Drugs: Gemcitabine, Cisplatin

Sites

1 site in 1 country

  • National Cancer Institute of MexicoMexico City, Mexico City, Mexico