Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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RPCEC |
Last refreshed on:
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4 March 2024 |
Main ID: |
RPCEC00000239 |
Date of registration:
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17/02/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Paclitaxel/Radiotherapy/Cisplatino for cervical cancer
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Scientific title:
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Weekly paclitaxel concurrent with radiation therapy/Cisplatin in patients with cervical cancer of clinical stages IIb- IVA: PACORTCC study - PACORTCC |
Date of first enrolment:
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07/03/2017 |
Target sample size:
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30 |
Recruitment status: |
Pending |
URL:
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https://rpcec.sld.cu/en/trials/RPCEC00000239-En |
Study type:
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Interventional |
Study design:
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Allocation: Randomized controlled trial. Masking: Single Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment
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Phase:
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2
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Ivan
Delgado-Enciso |
Address:
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Avenue Liceo de Varones 401, Colonia La Esperanza
28085
Colima
Mexico |
Telephone:
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Email:
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ivancoliman@hotmail.com |
Affiliation:
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Cancerology State Institute, Colima State Health Service |
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Name:
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Juan Carlos
Casarez-Price |
Address:
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Avenue Liceo de Varones 401, Colonia La Esperanza
28085
Colima
Mexico |
Telephone:
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dr.casarezprice@hotmail.com |
Email:
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Affiliation:
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Cancerology State Institute, Colima State Health Service |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Women older than 18 years 2. Clinical and histological diagnosis of CaCU EC IIB-IVA. 3. Histology of epidermoid carcinoma, adenocarcinoma, adenosquamous. 4. ECOG 0-2. 5. Patients with no history of Hepatic insufficiency or creatinine clearance less than 30mil / min. 6. Patients without sensory or motor neuropathy from any cause
Exclusion criteria: 1. Histology of small cells. 2. ECOG 3 or greater. 3. Diagnosis of second primary cancer. 4. Patients with diagnosed pregnancy.
Age minimum:
18 years
Age maximum:
None
Gender:
Male/Female
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Health Condition(s) or Problem(s) studied
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Genital Diseases, Female
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Cervical cancer
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Uterine Cervical Neoplasms
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Genital Neoplasms, Female
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Neoplasms
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Uterine Cervical Diseases
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Uterine Neoplasms
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Uterine Diseases
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Intervention(s)
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Control group: Radiotherapy (RT)+ Chemotherapy (CHT) RT: 50Gy of external RT in 25 sessions of 2Gy each, followed by 85-90Gy of brachytherapy. CHT: Cisplatin by intravenous route, weekly during RT at doses of 40mg / m2 for 6 doses
Experimental group: Radiotherapy (RT)+ Chemotherapy (CHT) + Paclitaxel RT: 50Gy of external RT in 25 sessions of 2Gy each, followed by 85-90Gy of brachytherapy. CHT: Cisplatin by intravenous route, weekly during RT at doses of 40mg / m2 for 6 doses. Paclitaxel will be recived by intravenous route concomitant with RT and CHT weekly at doses of 40 mg / m2 for 6 doses.
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Drug Therapy
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Chemoradiotherapy
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Cisplatin
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Paclitaxel
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Combined Modality Therapy
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Administration, Intravenous
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Brachytherapy
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Radiotherapy
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Primary Outcome(s)
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Complete response (RECIST 1.1). Measuring time: 12 weeks.
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Secondary Outcome(s)
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Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: Every week until week 12.
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Secondary ID(s)
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Not applicable
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Source(s) of Monetary Support
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Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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