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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: RPCEC
Last refreshed on: 4 March 2024
Main ID:  RPCEC00000239
Date of registration: 17/02/2017
Prospective Registration: Yes
Primary sponsor: Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Public title: Paclitaxel/Radiotherapy/Cisplatino for cervical cancer
Scientific title: Weekly paclitaxel concurrent with radiation therapy/Cisplatin in patients with cervical cancer of clinical stages IIb- IVA: PACORTCC study - PACORTCC
Date of first enrolment: 07/03/2017
Target sample size: 30
Recruitment status: Pending
URL:  https://rpcec.sld.cu/en/trials/RPCEC00000239-En
Study type:  Interventional
Study design:  Allocation: Randomized controlled trial. Masking: Single Blind. Control group: Active. Assignment: Parallel. Purpose: Treatment  
Phase:  2
Countries of recruitment
Mexico
Contacts
Name: Ivan    Delgado-Enciso
Address:  Avenue Liceo de Varones 401, Colonia La Esperanza 28085 Colima Mexico
Telephone:
Email: ivancoliman@hotmail.com
Affiliation:  Cancerology State Institute, Colima State Health Service
Name: Juan Carlos   Casarez-Price
Address:  Avenue Liceo de Varones 401, Colonia La Esperanza 28085 Colima Mexico
Telephone: dr.casarezprice@hotmail.com
Email:
Affiliation:  Cancerology State Institute, Colima State Health Service
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Genital Diseases, Female
Cervical cancer
Uterine Cervical Neoplasms
Genital Neoplasms, Female
Neoplasms
Uterine Cervical Diseases
Uterine Neoplasms
Uterine Diseases
Intervention(s)
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.
Drug Therapy
Chemoradiotherapy
Cisplatin
Paclitaxel
Combined Modality Therapy
Administration, Intravenous
Brachytherapy
Radiotherapy
Primary Outcome(s)
Complete response (RECIST 1.1). Measuring time: 12 weeks.
Secondary Outcome(s)
Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: Every week until week 12.
Secondary ID(s)
Not applicable
Source(s) of Monetary Support
Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico
Secondary Sponsor(s)
Medical School of the University of Colima, Mexico
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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