Actively Recruiting
Evaluation 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
Led by National Institute of Cancerología · Updated on 2025-05-28
140
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of two chemotherapy drugs, Cisplatin and Gemcitabine, given alongside radiotherapy as the first treatment for women with locally advanced cervical cancer who have other health conditions but good kidney function. This phase III clinical trial aims to compare these treatments to see which is better for patients with this type of cancer. The study is randomized and controlled, designed to test if Gemcitabine is not worse than Cisplatin in this setting. Participants will be randomly assigned to one of two groups: one group will receive weekly doses of Gemcitabine at 300 mg/m2 intravenously, and the other group will get weekly Cisplatin at 40 mg/m2 intravenously. Both groups will also receive external radiotherapy totaling 50.4 Gy over 5 weeks, followed by a 30 Gy brachytherapy treatment lasting 2 to 7 days. The treatment phase lasts about 1.5 months, with weekly visits during chemotherapy and radiotherapy. After treatment, participants will enter a 3-year follow-up phase with visits every 3 months. During the study, participants will have regular assessments to monitor safety, side effects, and treatment response using clinical exams and imaging like CT or PET-CT scans. Researchers will measure progression-free survival over 3 years and evaluate quality of life with questionnaires. They will also track adverse events and the presence of other health conditions. The full study is expected to last around 9 years, including patient recruitment and follow-up.
CONDITIONS
Brief 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 patients aged 18 years or older.
- For women of childbearing age: negative serum pregnancy test within 14 days before treatment and agreement to use approved contraception during the study and for 12 weeks after treatment.
- For postmenopausal women: previous bilateral oophorectomy, or age 60 years or older, or age under 60 with amenorrhea for at least 12 months and hormone levels within postmenopausal range.
- Diagnosis of locally advanced cervical cancer (stage IB2) confirmed by histology (epidermoid, adenocarcinoma, or adenosquamous).
- Candidates for concomitant chemotherapy and radiotherapy.
- ECOG performance status 0-2.
- Measurable disease by CT or MRI according to RECIST v1.1.
- No previous cancer treatment.
- Creatinine clearance of 60 ml/min or higher by CKD-EPI formula.
- Adequate blood and liver function: hemoglobin ≥10 g/L, leukocytes ≥4000/mm3, platelets ≥100,000/mm3, bilirubin ≤1.5 times upper normal limit, transaminases <1.5 times normal.
- Stable comorbidities allowed including controlled type 2 diabetes (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, and mild/inactive systemic lupus erythematosus (SLEDAI ≤4).
You will not qualify if you...
- Presence of a second type of cancer.
- Pregnant or breastfeeding women.
- 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.
- Concurrent treatment with another experimental drug.
- Social, family, or geographic conditions that may prevent study adherence.
- Disease progression during study.
- Treating physician decides change of therapy is needed.
- Withdrawal of consent.
- Unmanageable toxicity.
- Pregnancy or refusal to use contraception as required.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 6 weeks
Participants receive weekly chemotherapy with either gemcitabine or cisplatin concomitantly with radiotherapy for approximately 5 to 6 weeks.
Weekly visits for 5 to 6 weeks
Duration - 2 to 7 days
Participants receive brachytherapy following chemotherapy and radiotherapy.
1 to 2 visits depending on brachytherapy schedule
Duration - 3 years
Participants are monitored for safety and efficacy with visits every 3 months for up to 3 years after treatment.
Quarterly visits every 3 months for 3 years
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
J
Julissa Luvián, MSc, PhD
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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