NCT03101995

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

Recruiting now Phase 2 Last updated 28 May 2025

What this trial tests

Phase 2 trial testing Gemcitabine in Cervical Cancer in 18 participants. Currently enrolling.

Timeline

16 January 2018

Primary endpoint
1 July 2025

1 November 2025

Quick facts

Lead sponsor	National Institute of Cancerología
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	16 January 2018
Primary completion	1 July 2025
Estimated completion	1 November 2025
Sites	1 location across Mexico

Drugs / interventions tested

• Gemcitabine (gemcitabine) — full drug profile →

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →

Sponsor

National Institute of Cancerología

Who can join

Adults 18 to 70, female only, with Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Application of Radiosensitizers in Cancer Radiotherapy.
   Gong L, Zhang Y, Liu C, Zhang M, et al · · 2021 · cited 288× · PMID 33603370 · DOI 10.2147/ijn.s290438