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Patients with non small cells lung cancer (NSCLC) and brain metastasis.
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Revision of 20 January 2017 - 1:29pm:
Patients with non small cells lung cancer (NSCLC) and brain metastasis.
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:
Use of hR3 MAb and radiotherapy to treat patients with non small cells lung cancer (NSCLC) and brain metastasis.
Secondary indentifying numbers:
IIC RD-EC079
Issuing authority of the secondary identifying numbers:
Center of Molecular Immunology (CIM)
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Government funds
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 the Quality of Drugs(CECMED)
Authorization date :
15/02/2006
Reference number:
281/05.023.05B
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Javier
Last name:
Figueredo
Medical Specialty :
MD. 1st degree Specialist in Neurosurgery.
Affiliation:
Center of Researches Surgical-Medical (CIMEQ)
Postal address:
216 street, corner 11-B, Siboney
City:
Havana
Country:
Cuba
Zip Code:
12100
Telephone:
+53-78581000
Email address:
email@not.entered
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:
Havana City, Hermanos Ameijeiras Hospital, Elia Neninger, MD. 2nd degree Specialist in Oncology.
Matanzas, José Ramón López Tabrane Hospital, Eduardo Santiesteban Alvarez, MD. 1st degree Specialist in Oncology.
Research ethics committees:
Center of Researches Surgical-Medical (CIMEQ), November 1th, 2005.
Hermanos Ameijeiras Hospital, December 20, 2006.
Jose Ramon Lopez Tabrane Hospital, September 19, 2007.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
08/09/2006
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:
Non-small cells lung cancer with brain metastasis
Health condition(s) code:
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Diseases
Respiratory Tract Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intervention(s):
2 treatment groups, A and B. Group A. Radiant+HR3 MaB palliative therapy Palliative therapy. Palliative radiant treatment (30 Gy) for 2 weeks. hR3 MAb. The group will receive six 200mg HR3 MAb administrations every week, for 6 consecutive weeks, along with radiotherapy. Group B. Radiant palliative therapy The group will receive the palliative therapy indicated for metastatic disease, just as Group A.
Intervention code:
Antibodies, Monoclonal, Humanized
Radiotherapy
Antibodies, Monoclonal
Palliative Care
Intervention keyword:
AcMh-R3
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):
Survival time, measuring time: 12 months.
Key secondary outcomes:
Global objective response, duration of disease control and quality of life, measuring time: 12 months.
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- Patients with non small cell lung cancer (NSCLC) confirmed by Pathological Anatomy techniques. 2-Patients with one or more measurable brain metastatic lesions who, at the time of inclusion, are not eligible for surgical treatment (total exeresis), defined as those than can be accurately measured in, at least, one dimension (meaning the greater diameter) using imaging techniques (CAT and/or NMR). 3- The study includes metastasis detected during diagnosis and evolving metastasis. 4- Patients could have received any previous onco-specific treatment (surgery, chemotherapy, radiotherapy or any other) for primary lung tumor, provided that such treatment had ended, at least, 4 weeks before being included in the study and who, at the time of inclusion, are only receiving palliative radiotherapy to treat brain metastatic disease. The trial can also include phase IV patients who are only on radiotherapy to treat lung primary tumor and those who are concurrently under radiotherapy for brain metastasis. 5- Patients with brain metastasis diagnosed up to 6 weeks earlier. 6- Reproductive-age patients should have a negative pregnancy test and all patients included in the trial should use effective contraceptive methods. 7- Age >= 18 years. 8- Life expectancy >= 12 weeks. 9- General health condition according to the Karnosfsky Index >= 60. 10- Laboratory parameters within the normal limits, defined as: hematopoietic parameters: haemoglobin>= 9 g/l, total leukocytes >= 4 x 109 cells/l, platelets >= 100 x 109/l, Liver: liver functioning within normal limits and without liver conditions confirmed by TGP, TGO or alkaline phosphatase. Kidney function: serum creatinine<132 mmol/l, creatinine clearing within normal limits. 11- Patients who sign the informed consent document.
Exclusion criteria:
1- Patients on any monoclonal antibody. 2- Pregnancy or breastfeeding. 3- Patients who, at the time of inclusion, have any decompensated related chronic disease (for example: cardiopathy, diabetes, high blood pressure). 4- Patients with history of hypersensitivity to this or any other similar biological product. 5- Fever, severe septic processes, or acute or serious allergic conditions. 6- Presence of a second primary tumor. 7- Patients who, at the time of inclusion, are participating in another clinical trial.
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:
Open
Control group:
Active
Study design:
Parallel
Phase:
2
Target sample size:
30
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:
Amparo
Middle Name:
Emilia
Last Name:
Macias Abraham
Specialty:
Second Degree Specialist in Clinical Biochemistry
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
216 street, corner 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
CP 16040, Box11600
Telephone:
(537) 271-7933, Ext 224
Email :
amparo@cim.sld.cu
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:
Amparo
Middle Name:
Emilia
Last Name:
Macias Abraham
Specialty:
Second Degree Specialist in Clinical Biochemistry
Affiliation:
Center of Molecular Immunology (CIM)
Postal Address:
216 street, corner 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
CP 16040, Box11600
Telephone:
(537) 271-7933, Ext 224
Email :
amparo@cim.sld.cu
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:
RPCEC00000016
Date of Registration in Primary Registry:
2010-12-29
Record Verification Date:
2017/01/20
Next update date:
2018/01/20
Link to the spanish version:
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