Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Cancerología
Collaborators:
Instituto Nacional de Cardiologia Ignacio Chavez Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran