Assessment of Gemcitabine as Chemoradiotherapy in Patients With Locally Advanced Carcinoma of Cervix and Renal Disease
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|ClinicalTrials.gov Identifier: NCT03101995|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: Gemcitabine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase II open, single arm, national, non-randomized clinical trial; to evaluate safety of gemcitabine in patients with locally advanced cervical cancer and renal dysfunction, referring to the INCAN.|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 16, 2018|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Gemcitabine doses: 300 mg/m2/week for 6 weeks.
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.
Other Name: Gemzar
- Glomerular Filtration Rate [ Time Frame: During and every 3 months after completing concomitant QT/RT treatment, for the first two years, and every 6 months for the following 3 years. ]
Safety of gemcitabine regarding renal function will be assessed through glomerular filtration rate.
An improvement of 10 ml/min/1.73m2 as compared to basal glomerular rate is expected by the end of treatment.
- Toxicity [ Time Frame: During and every 3 months after completing concomitant QT/RT treatment, for the first two years, and every 6 months for the following 3 years. ]Toxicity will be evaluated according to the toxicity criteria of CTCEA v. 4.03. A toxicity index of <4 is expected during treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101995
|Contact: Lucely C Cetina, MD, M.Sc.||+email@example.com|
|Contact: Roberto Jiménez, MD, M.Sc.||+firstname.lastname@example.org|
|National Institute of Cancer||Recruiting|
|Mexico City, DF, Mexico, 14080|
|Contact: Lucely Cetina, MD, MSc +521555 4851237 email@example.com|
|Principal Investigator:||Lucely C Cetina, MD, M.Sc.||National Institute of Cancerología|