Using Gemcitabine for Cervical Cancer Treatment in Patients with Kidney Issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of gemcitabine as a chemoradiotherapy option for women with locally advanced cervical cancer who also have renal disease. Given the nephrotoxic effects of the standard treatment, cisplatin, this study aims to determine if gemcitabine can provide a safer alternative while still improving patient outcomes. The trial will involve administering gemcitabine alongside radiotherapy to assess its impact on overall survival and local recurrence rates. Participants will be closely monitored for side effects and treatment efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Lucely C Cetina, MD, M.Sc. — National Institute of Cancerología
• Study coordinator: Lucely C Cetina, MD, M.Sc.
• Email: lucelycetina.incan@gmail.com
• Phone: +5215554851237

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

  This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.

  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

  This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

• One-Finger Technique to identify the left upper ureter during para-aortic lymphadenectomy

  This study tests a new surgical method to help surgeons find the left upper ureter during open para-aortic lymphadenectomy in women with gynecologic cancers.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07895212

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.