CERVICONC-II-300 study

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.

Scientific title:

Intratumoral application of CIGB 300 concomitant to chemo radiotherapy in patients with stage IB2 and II cervical cancer.

Secondary indentifying numbers:

IG/CIGB300I/CC/1806

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB). Ministry of Public Health, CUBA.

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:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

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

First name:

Gustavo

Midle name:

de Jesus

Last name:

Crespo Campos

Medical Specialty :

1st grade specialist in Gynecology and Obstetrics

Affiliation:

Oncology Hospital "Marie Curie"

Postal address:

Carretera Central Oeste esquina Madame Curie

City:

Camaguey

Country:

Cuba

Zip Code:

70700

Telephone:

+53-32283905

Email address:

gustavoj.cmw@infomed.sld.cu [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:

Cuba

Clinical sites:

Pinar del Rio, Oncologic Hospital "Tercer Congreso", Idalmis Mesa Vazquez, 1st degree specialist in Oncology.

Havana, Gynecobstetric Hospital "Ramon Gonzalez Coro", Raysa Ruiz Lorente, 1st Degree Specialist in Oncology.

Matanzas, Surgical Clinical Hospital "Faustino Perez", Ihosvany Enrrique Carreño, 1st Degree Specialist in Oncology.

Cienfuegos, University Hospital "Gustavo Aldereguia Lima", Daniel Alejandro Diaz Conde, 1st Degree Specialist in Oncology.

Villa Clara, University Hospital "Celestino Hernandez", Luis Alfredo Estevez Cobo, 1st Degree Specialist in Oncology.

Sancti Spiritus, Provincial Hospital "Camilo Cienfuegos", Yanelis Leon Duran, 1st Degree Specialist in Oncology.

Ciego de Avila, Provincial Hospital "Antonio Luaces Iraola", Saray Maria Lopez Gonzalez, 1st Degree Specialist in Oncology.

Granma, Clinical Surgical Hospital "Celia Sanchez Manduley", Darcy Leonel Garcia Piña, 1st Degree Specialist in Gynecology and Obstetrics.

Granma, University Hospital "Carlos Manuel de Cespedes", Yanet Caridad Carmona Valera, 1st Degree Specialist in Oncology.

Santiago de Cuba, General Hospital "Juan Bruno Zayas", Alejandro Rodriguez Tabares, 1st Degree Specialist in Gynecology and Obstetrics.

Santiago de Cuba, Oncologic Hospital "Conrado Benitez", César Gonzalez Alonso, 1st Degree Specialist in Oncology.

Guantánamo, General Hospital "Agostinho Neto", Agustina Robert, 1st Degree Specialist in Oncology.

Research ethics committees:

Oncologic Hospital "Marie Curie", April 30, 2018.

Oncologic Hospital "Tercer Congreso", April 25, 2018.

Gynecobstetric Hospital "Ramón González Coro", May 27, 2018.

"Faustino Perez" Surgical Clinical Hospital, May 27, 2018.

University Hospital "Gustavo Aldereguia Lima", April 27, 2018.

University Hospital "Celestino Hernandez", April 18, 2018.

Provincial Hospital "Camilo Cienfuegos", April 18, 2018.

Provincial Hospital "Antonio Luaces Iraola", April 26, 2018.

Clinical Surgical Hospital "Celia Sanchez Manduley", April 26, 2018.

University Hospital "Carlos Manuel de Cespedes", April 25, 2018.

General Hospital "Juan Bruno Zayas", April 26, 2018.

Oncologic Hospital "Conrado Benitez", April 23, 2018.

General Hospital "Agostinho Neto", April 24, 2018.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/10/2018

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 in stages IB2 and II.

Health condition(s) code:

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Intervention(s):

Group I (Control)-Placebo: Chemoradiotherapy (CRT) consisting of cisplatin (40 mg / IMC) once a week as a radiosensitizer for 25 sessions of external radiotherapy, followed by two sessions of Brachytherapy + placebo of CIGB-300 (daily intratumoral injection for 3 days in the 1st, 3rd and 5th week of treatment with QRT, for a total of 9 applications). Group II (Experimental) CIGB-300 15mg: Chemoradiotherapy (CRT) consisting of cisplatin (40 mg / IMC) once a week as a radiosensitizer for 25 sessions of external radiotherapy, followed by two sessions of Brachytherapy + CIGB-300 at a dose of 15 mg (daily intratumoral injection for 3 days in the 1st, 3rd and 5th week of treatment with QRT, for a total of 9 applications). Group III (Experimental) CIGB-300 35mg: Chemoradiotherapy (CRT) consisting of cisplatin (40 mg / IMC) once a week as a radiosensitizer for 25 sessions of external radiotherapy, followed by two sessions of Brachytherapy + CIGB-300 at a dose of 35 mg (daily intratumoral injection for 3 days in the 1st, 3rd and 5th week of treatment with QRT, for a total of 9 applications).

Intervention code:

Chemoradiotherapy

Drug Therapy

Cisplatin

Brachytherapy

Peptides

Antineoplastic Agents

Combined Modality Therapy

Placebos

Injections, Intralesional

Intervention keyword:

CIGB-300

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):

Tumor response (It will be evaluated according to the criteria of RECIST (Response evaluation criteria in solid tumors). Patients will be classified as: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD)). Measurement time: at 3 and 6 months after end of treatment.

Key secondary outcomes:

1. Time to reach the clinical response (in weeks, according to the results of the clinical evaluation, digital rectal examination and digital colposcopy). Measurement time: at the beginning, in weeks 3 and 5 (before the first application of the research product) and in the 7th week (one week after the end of treatment). 2. Free survival of progression (in months, time from inclusion in the study to recurrence of the tumor or death from any cause). Measurement time: 24 months. 3. Overall survival (in months, Time from randomization until death from any cause). Measurement time: 24 months. 4. Quality of life (according to EORTC QLQ-C30 and QLQ-LC13). Measurement time: At baseline, 3 and 6 months, 9, 12, y 24 after treatment. 5. Biological variables (in plasma, numerical or qualitative values of predictive markers of response to CIGB-300, such as levels of protein B23 / PDL1 / CD4-CD8 / P16 and Ki-67, behavior of circulating tumor DNA, etc). Measurement time: at the beginning, at 24 hours, 7 days, 3 months and 6 months after treatment. 6. Adverse events (-Occurrence of adverse events (Yes, No) -Description of the adverse event (name of the event) -Intensity (mild, moderate, severe)). Measurement time: 24 hours after every administration of the intervention and, 3 months after treatment

Selection criterias

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

Gender:

Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1) Patients that meet the histological diagnostic criteria of squamous cell carcinoma or adenocarcinoma, stage IB2-II. 2) Patients with ECOG 0-1. 3) Informed consent signed by the patient. 4) Patients with normal hepatic, renal and hematological functions.

Exclusion criteria:

1) Pregnancy and lactation. 2) Patients included in another clinical trial and who have received any biological therapy in research, including active or passive immunotherapy in the last 6 months. 3) Chronic decompensated diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, malignant neoplasms, epilepsy, severe mental depression). 4) Allergic diseases (example, persistent bronchial asthma). 5) Acute infectious disease that prevents the application of the research product. 6) Diseases that compromise the patient's state of consciousness or their ability to give informed consent or collaborate in the trial. 7) Extensive tumor necrosis or endophytic tumor that prevents the application of the product as provided in this protocol. 8) Conditions that prevent the realization of high-field magnetic resonance imaging: cardiac pacemaker, implantable cardiac defibrillator; cochlear implant, vascular, metallic clips, vascular prosthesis, vascular stent, IUD, orthopedic prostheses, fragments of metals in the body (like projectiles of firearm), tattoos. 9) Use of intrauterine devices (IUDs), which contain copper. 10) Patients with claustrophobia (assess study under sedation). 11) Obese patients that exceed the limit of the gantry (tube) of the resonator.

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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

144

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:

Idania

Last Name:

Baladron Castrillo

Specialty:

2nd grade specialist in Gynecology and Obstetrics.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+53-72085887, +53-72087465

Email :

idania.baladron@cigb.edu.cu [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:

Silvio

Middle Name:

Ernesto

Last Name:

Perea Rodriguez

Specialty:

Doctor of Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+53-72716022

Email :

silvio.perea@cigb.edu.cu [3]

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:

RPCEC00000285

Date of Registration in Primary Registry:

07/08/2018

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [4]