Paclitaxel/Radiotherapy/Cisplatino for cervical cancer

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

PACORTCC

Scientific title:

Weekly paclitaxel concurrent with radiation therapy/Cisplatin in patients with cervical cancer of clinical stages IIb- IVA: PACORTCC study

Acronym of Scientific Title:

PACORTCC

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Cancerology State Institute, Colima State Health Service (SSA-Colima), Mexico

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Juan

Midle name:

Carlos

Last name:

Casarez-Price

Medical Specialty :

Medical oncology

Affiliation:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima)

Postal address:

Avenue "Liceo de Varones" 401, Colonia La Esperanza

City:

colima

País:

Mexico

Zip Code:

28085

Telephone:

+52-3123162740

Email address:

dr.casarezprice@hotmail.com [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Mexico

Clinical sites:

Not applicable

Research ethics committees:

Cancerology State Institute of the health services of the state of Colima (SSA-Colima), December 13th, 2016

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

07/03/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Cervical cancer

Health condition(s) code:

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Neoplasms

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.

Intervention code:

Paclitaxel

Radiotherapy

Brachytherapy

Cisplatin

Chemoradiotherapy

Drug Therapy

Combined Modality Therapy

Administration, Intravenous

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Complete response (RECIST 1.1). Measuring time: 12 weeks.

Key secondary outcomes:

Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: Every week until week 12.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Single Blind

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivan

Last Name:

Delgado-Enciso

Specialty:

General Medicine and Molecular Biology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

País:

Mexico

Zip Code:

28085

Telephone:

+52-3121521435

Email :

ivancoliman@hotmail.com [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Juan

Middle Name:

Carlos

Last Name:

Casarez-Price

Specialty:

Medical oncology

Affiliation:

Cancerology State Institute, Colima State Health Service

Postal Address:

Avenue Liceo de Varones 401, Colonia La Esperanza

City:

Colima

País:

Mexico

Zip Code:

28085

Telephone:

+52-3123162740

Email :

dr.casarezprice@hotmail.com [1]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000239

Date of Registration in Primary Registry:

17/02/2017

Record Verification Date:

2017/02/17

Next update date:

2018/02/17

Link to the spanish version:

Click here [3]