💬In plain words
What the trial is, and whether it could suit you
From the global burden of Cervical Cancer (CC), 85% occurs in developing countries, representing 12% of cancer in women. In Mexico CC ranks second in incidence and mortality among women. The National Institute of Cancer in Mexico (lNCAN) receives annually about 500 patients with CC, 80% of which are diagnosed with locally advanced disease. Furthermore, 10 to 20% of these present kidney deterioration. The main reason for kidney disease is ureteral obstruction, other causes include age and comorbidities, such as diabetes and hypertension. The standard treatment for locally advanced disease consists in concomitant chemo-radiotherapy based on cisplatin (QT-RT), followed by brachytherapy, with an absolute benefit of 10%. However, the use of cisplatin in patients with renal disease may be questionable, considering it is a nephrotoxic treatment. Given that renal dysfunction limits the standard
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📋 Eligibility rules (as published)
Inclusion criteria.
1. Patients who give their written consent to participate in the study.
2. Women, 18-70 years of age, considering the following criteria:
• In women of childbearing age: i. Negative serum pregnancy test at baseline (14 days prior to the start of QT-RT).
ii. The patient must accept the use of any contraceptive method approved by the attending physician during the study and 12 weeks after the end of treatment.
• Postmenopausal women must meet at least one of the following parameters for eligibility: i. Prior bilateral oophorectomy ii. Age ≥ 60 years iii. Age \< 60 years, with amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal parameters.
3. Diagnosed with CC IB2-IVA, with or without retroperitoneal lymph nodes (para-aortic), smaller than 2 cm.
4. With histologic confirmation of squamous carcinoma, adenosquamous carcinoma, adenocarcinoma or glassy cells carcinoma.
5. Without previous treatment and medically able to receive gemcitabine.
6. Disease measurable by CT and/or MRI according to RECIST (v1.1) criteria.
7. Functional status of 0-3 according to WHO criteria.
8. Renal dysfunction defined by glomerular filtration (GF) \<60 ml/min/1.73m2 calculated by the CKD-EPI formula.
9. Normal hematologic and liver function, as defined by the following parameters:
* Hemoglobin \> 10g/L. (Transfusion prior to the treatment is allowed to reach this level of hemoglobin).
* Leucocytes \> 4000/mm3.
* Platelets \> 100,000/mm3.
* Total Bilirubin ≤1.5 times the upper normal limit (UNL).
* Transaminases \< 1.5 times the UNL.
10. Normal PA chest radiograph.
Exclusion criteria.
1. Patients with prior or concomitant malignancy, except non-melanoma skin carcinoma.
2. Patients with diabetes and/or hypertension with retinopathy or albuminuria \>300.
3. Patients with evidence of active TB infection.
4. Patients infected with Human Immunodeficiency Virus (HIV).
5. Patients with a history of Systemic Lupus Erythematosus and other rheumatologic diseases that cause kidney damage.
6. Patients with vesicovaginal or vesicorectal fistula at the time of diagnosis.
7. Patients with uncontrolled intercurrent diseases including active infections that contraindicate QT, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, decompensated diabetes, difficult control hypertension and psychiatric illness.
8. Concomitant treatment with other experimental drugs.
9. Social, family or geographical conditions that suggest a poor adherence to the study.
Study discontinuation criteria.
1. Evidence of disease progression, if the researcher considers that the patient would benefit more with other therapy.
2. At the request of the patient.
3. By unacceptable toxicity.
4. Pregnancy.
Violation of starting criteria. Criteria must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study.
National Institute of Cancer
Mexico City, Mexico
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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