Actively Recruiting
Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
Led by National Institute of Cancerología · Updated on 2025-05-28
140
Participants Needed
1
Research Sites
529 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Concomitant Chemo-radiotherapy With Cisplatine vs Gemcitabin in Locally Advanced Cervicouterine Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Female aged 18 years or older.
- For women of childbearing age: negative pregnancy test within 14 days before treatment and agreement to use approved contraception during study and 12 weeks after.
- For postmenopausal women: either previous bilateral oophorectomy, age 60 years or older, or age under 60 with at least 12 months amenorrhea and hormone levels in postmenopausal range.
- Histologically confirmed cervical cancer stage IB2.
- Candidates for concomitant chemotherapy and radiotherapy.
- ECOG performance status 0 to 2.
- Measurable disease by CT and MRI according to RECIST v1.1.
- No prior cancer treatment.
- Creatinine clearance of 60 ml/min or higher.
- Adequate blood and liver function: hemoglobin 10 g/l or higher, leukocytes 4000/mm3 or higher, platelets 100,000/mm3 or higher, bilirubin ≤1.5 times upper limit, transaminases <1.5 times upper limit.
- Diagnosed with certain comorbidities: type 2 diabetes with fasting glucose <250 mg/dl, grade 1 or 2 hypertension, Child Pugh A liver disease, stable ischemic heart disease without angina or recent heart attack, compensated heart failure NYHA class I, or mild/inactive systemic lupus erythematosus (SLEDAI ≤4).
You will not qualify if you...
- Presence of a second cancer.
- Pregnant or breastfeeding.
- Small cell or neuroendocrine cervical cancer.
- Impaired kidney function with GFR ≤60 ml/min.
- History of active tuberculosis.
- HIV infection.
- Vesicovaginal or vesicorectal fistulas at diagnosis.
- Receiving another experimental drug.
- Social, family, or geographic conditions likely to prevent study adherence.
- Treatment withdrawal criteria: disease progression, physician decision for therapy change, withdrawal of consent, unmanageable toxicity, pregnancy, or refusal to use contraception as directed.
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Institute of Mexico
Mexico City, Mexico City, Mexico, 14080
Actively Recruiting
Research Team
L
Lucely C Cetina, MD, MSc
CONTACT
J
Julissa Luvián, MSc, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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