Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201702001974160 Date of Approval: 15/01/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intratumoral Hyperthermic Chemotherapy Injection in Peripheral Non-Small Cell Lung Cancer; Efficacy and Safety
Official scientific title Intratumoral Hyperthermic Chemotherapy Injection in Peripheral Non-Small Cell Lung Cancer; Efficacy and Safety
Brief summary describing the background and objectives of the trial The aim of this study is to assess the efficacy and safety of percutaneous transthoracic injection of hyperthermic chemotherapy as a palliative treatment of peripheral inoperable non small cell lung cancer to conventionally systemic used protocol of chemotherapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,lung cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/01/2017
Actual trial start date
Anticipated date of last follow up 25/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised closed envelope method Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group hyperthermic chemotherapeutic agent 30% of total chemotherapy dose will be injected divided in 6 times with week interval 2 months image guided CT or US percutanous injection 12
Experimental Group normothermic chemotherapeutic agen 30% of total chemotherapy dose will be injected divided in 6 times with week interval 2 months image guided CT or US percutanous injection 12
Control Group systemic cemotherapy conventional chemotherpy protocol 2 months 16 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with peripheral lung cancer planned to be treated by chemotherapy who include all of the following: 1- Histologically-diagnosed, peripheral NSCLC. 2- Patients who are not candidate for surgical treatment because of poor cardiopulmonary status, inoperable advanced stage of lung cancer or refusal of surgery 3- The patients are fit for chemotherapy with adequate bone marrow reserve: ¿ White blood cell count >3500/mm3. ¿ Neutrophil count >1800/mm3. ¿ Hemoglobin >10 gm /dL. ¿ Haematocrit value >30% Patients with one or more of the following will be excluded: 1. Patient is operable and planned for surgery. 2. Tumors infiltrating the main stem bronchi, trachea and/or mediastinum as detected by fiberoptic bronchoscopy (FOB) and or CT chest (central bronchogenic carcinoma). 3. Uncooperative patients. 4. Patient with uncorrectable bleeding diathesis. 5. Lung cancer other than NSCLC (small cell lung cancer, metastatic lung cancer, lymphoma, sarcoma, others ). 6. Platelet count ¿ 50,000 mm3 and/or prothrombin time ¿ 50%. 7. Serum bilirubin more than 2.5 mg/dL, ALT and AST > 3 times normal level and creatinine > 1.5 mg/dL. 8. Patient with severe pulmonary dysfunction. 9. Patient with uncompensated cardiac comorbidities. 10. Hypersensitivity to cisplatin. 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/01/2017 IRB(institional research board) of faculty of medicine , Mansoura university
Ethics Committee Address
Street address City Postal code Country
Elgomhouria St mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome A. Clinical evaluation: It depends on recording the changes in patients¿ symptoms, performance status, and quality of life. B. Radiological evaluation will be done by: Chest X-ray and CT of the chest. C. Histopathological examination by tru cut biopsy after 6 months. 3,6 months
Secondary Outcome survival 6months and monthly till end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospitals, Chest Department, Oncology center of Mansoura University. Elgomhouria St mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine,Mansoura university Elgomhouria St., mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine,Mansoura university Elgomhouria St., mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mohamed adel mohamed hassan tohlob 111 Mahmoud bek shahin - mansoura -dakaklyia -egypt mansoura 35516 Egypt
Ahmed Saad El-Morsi Elgomhouria St mansoura 35516 Egypt
asem abdelhamid hewidy Elgomhouria St mansoura 35516 Egypt
mohamed awad ebrahim Elgomhouria St mansoura 35516 Egypt
lucy abd-elmaaboud suliman Elgomhouria St mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed adel mohamed tohlob dr_mohamedtohlob@mans.edu.eg 01112300281 111 Mahmoud bek shahin - mansoura -dakaklyia -egypt, 6 floor apartment 1
City Postal code Country Position/Affiliation
mansoura 35516 Egypt assistant lecturer of Chest medicine ,faculty of medicine , Mansoura university
Role Name Email Phone Street address
Public Enquiries mohamed adel mohamed tohlob dr_mohamedtohlob@mans.edu.eg 01112300281 111 Mahmoud bek shahin - mansoura -dakaklyia -egypt, 6 floor apartment 1
City Postal code Country Position/Affiliation
mansoura 35516 Egypt assistant lecturer of Chest medicine ,faculty of medicine , Mansoura university
Role Name Email Phone Street address
Scientific Enquiries asem abdelamid hewidy ahewidy@yahoo.com 01005210674 Elgomhouria St.,
City Postal code Country Position/Affiliation
mansoura 35516 Egypt assistant professor of Chest medicine ,faculty of medicine , Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information