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RECRUITING

NCT03101995

PHASE2

Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

Sponsor: National Institute of Cancerología

View on ClinicalTrials.gov

Summary

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 treatment efficiency because of the widely known nephrotoxicity of cisplatin, in most Cancer Centers of our country, patients with renal dysfunction receive only radiation therapy, even though it has proven less effective than concomitant QT-RT, limiting disease-free and overall survival of these patients. Venook et al. used gemcitabine as a radiosensitizer in patients with cancer and renal dysfunction. Our group, has observed encouraging results using gemcitabine as an alternative to cisplatin in concomitant treatment with radiotherapy, in CC patients with renal insufficiency. 89% of patients had complete response and improvement in renal function, with an enhanced creatinine clearance after treatment. Therefore, it is necessary to explore the safety of gemcitabine as an alternative treatment for CC patients with locally advanced disease and renal deterioration. We propose this clinical trial to assess the safety of treatment with gemcitabine and specifically on renal function in patients with renal deterioration. It is important to take into consideration that CC in advanced stages produces pain, transvaginal fetid discharge and general discomfort. It also causes side effects secondary to renal failure such as nausea, vomiting, fatigue, anemia, among others. These effects have a significant impact on the quality of life of these patients. Cancer treatment and its side effects, besides the implications of a nephrostomy catheter or ileostomy bag, determine the deterioration in the quality of life of the patient, during and sometimes after treatment. Thus it is of utmost importance to evaluate the factors that could help improve the quality of life of patients and explore the factors that deteriorate it. This clinical trial aims to generate scientific evidence to help make the best decisions concerning the treatment of patients with cervical cancer and renal impairment, and the impact on their quality of life.

Official title: A Phase II Clinical Trial to Evaluate the Potential of Concomitant Chemoradiotherapy With Gemcitabine in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-01-16

Completion Date

2025-11-01

Last Updated

2025-05-28

Healthy Volunteers

Conditions

Cervical Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine 300 mg/m2, prepared in 0.5 liters of sodium chloride 0.9%, IV administered in 30 minutes weekly for a maximum of 6 weeks. Radiotherapy will start the first week, or as soon as the blood count is normal or the patient has recovered after blood transfusion. Radiotherapy will be applied, using an external beam releasing 40-50.4 Gy in 20-28 fractions: 1.8 Gy/day for 5 days/week, during 4 to 6 weeks. Intracavitary brachytherapy will be added to reach a total EQD2 dosage (α/β=10) of 78-86 Gy.

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.

Locations (1)

National Institute of Cancer

Mexico City, Mexico City, Mexico