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.: PACTR201901862142418 Date of Approval: 16/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gemcitabine with the standard dose (1000 mg/m2) is equal to low dose (250 mg/m2) with just prolongation of the infusion time in Patients with Advanced Pancreatic cancer
Official scientific title Randomized Phase II Study Comparing the Standard Protocol of Gemcitabine with Low Dose Gemcitabine over 6 Hours in Patients with Advanced Pancreatic Adenocarcinoma
Brief summary describing the background and objectives of the trial Phase II Randomized study During the study period from March 2016 to January 2018, 100 patients from 2 oncological centers in Upper Egypt (Medical Oncology Department, South Egypt Cancer Institute, Assiut University, Assiut Governorate and Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Sohag University, Sohag Governorate) were randomly assigned as follows: standard dose gemcitabine (n = 50) and low dose gemcitabine over 6-hour infusion (n= 50). Seven patients were excluded from standard arm due to death before starting treatment (n=3), lost follow up after 1st cycle without assessment (n=2), and patient demand (n=2); while four patients from the experimental arm were excluded from analysis, two of them died before first assessment and the remaining 2 patients withdrew their consent. Last day of follow up was 31 May 2018 as the study was completed and prepared for analysis. Eighty nine patients were analyzed for study endpoints; 43 patients in standard arm and 46 patients in LD6H arm. The primary end points were progression free survival (PFS), defined as the time from the start of treatment to disease progression or death from any cause, whichever came first, and safety through assessment toxicity profile based on CTCAE. Secondary efficacy end points were overall survival (OS; defined as the time from the start of treatment to disease progression, death from any cause, or date of last follow up, whichever came first.), overall response rate (ORR; defined as sum of rates of complete response (CR) and partial response (PR) to chemotherapy), and disease control rate (DCR; defined as sum of rates of stable disease (SD), complete response, and partial response).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Pancreatic cancer low dose gemcitabine
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 05/02/2016
Actual trial start date 28/03/2016
Anticipated date of last follow up 31/01/2018
Actual Last follow-up date 26/06/2018
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 89
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
254 SECI-IRB, IORG0006563, approved No: 254
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Gemcitabine 250 mg/m2 body surface area over 6 hours Intravenous infusion 46
Control Group Gemcitabine 1000 mg/m2 body surface area 30 minute Intravenous Infusion 43 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with advanced pancreatic cancer in males or females with age of 18 years or older, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, chemotherapy-naïve, and adequate hematologic, hepatic, and renal functions. 1. Patient refuses to be enrolled in study. 2. Contraindication to gemcitabine 3. Concurrent anticancer or radiation therapy.  Start of study therapy must be at 4 weeks after completion of previous anticancer therapy and 2 weeks from the date of last radiation. 4. Use of gemcitabine within the past 3 months with progression. 5. Any psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant or nursing women. 7. Synchronous malignancies i.e associated other body cancers. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 28/03/2016 South Egypt Cancer Institute ethics committee
Ethics Committee Address
Street address City Postal code Country
El-methaq street Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary end points were progression free survival (PFS), defined as the time from the start of treatment to disease progression or death from any cause, whichever came first, and safety through assessment toxicity profile based on CTCAE. date of the start of treatment
Secondary Outcome Secondary efficacy end points were overall survival (OS; defined as the time from the start of treatment to disease progression, death from any cause, or date of last follow up, whichever came first.), overall response rate (ORR; defined as sum of rates of complete response (CR) and partial response (PR) to chemotherapy), and disease control rate (DCR; defined as sum of rates of stable disease (SD), complete response, and partial response). date of the start of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
South Egypt Cancer Institute Elmethaq Streat Assiut 71511 Egypt
Clinical Oncology and Nuclear Medicine Department Nile Street Sohag 82749 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
South Egypt Cancer Institue Assiut University Ministery of high Education and Ministery of Health Elmethaq Streat Assiut 71511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South Egypt cancer Institute Elmethaq Streat Assiut 71511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Elsayed Mostafa Ali Nile Street, Faculty of Medicine, Sohag University Sohag 82749 Egypt
Mohamed Medhat Samir Elmethaq Street Assiut 71511 Egypt
Tarek Mohamed Elsaba Pathology Department, South Egypt Cancer Institute, Assiut University, Egypt Assiut 71511 Egypt
Engy Adel Shafek Clinical Pathology Department, South Egypt Cancer Institute, Assiut University, Egypt Assiut 71511 Egypt
Amr Farouk Morad Radiology Department, South Egypt Cancer Institute, Assiut University, Egypt Assiut 71511 Egypt
Matta Gerges Medical Oncology Department, South Egypt Cancer Institute, Assiut University, Egypt Assiut 71511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Salah Khallaf salahmab@yahoo.com 00201004081234 Elmethaq Streat
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Lecturer of Medical OncologyDr
Role Name Email Phone Street address
Principal Investigator Elsayed Ali sayedmostafa07@hotmail.com 00201001638744 Nile Street
City Postal code Country Position/Affiliation
Sohag 82749 Egypt Assisstent Professor of Clinical OncologyProf
Role Name Email Phone Street address
Public Enquiries Mona Sayed mmsaamz@yahoo.com 01062049092 Elmethaq Street
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Assisstent Prof of clinical Oncology Prof
Role Name Email Phone Street address
Principal Investigator Ahmed Maklad ahmaklad2003@yahoo.com 02201093986563 Nile Street
City Postal code Country Position/Affiliation
Sohag 82749 Egypt Lecturer of Clinical Oncology Dr
Role Name Email Phone Street address
Principal Investigator Anwar Amin anwar71@aun.edu.eg 00201095404135 Elmethaq street
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Prof of Surgical Oncology Prof
Role Name Email Phone Street address
Principal Investigator Salah Khallaf salahmab76@yahoo.com 00201004081234 Elmethaq street
City Postal code Country Position/Affiliation
Assiut 71511 Egypt Lectutrer of Medical Oncology Dr
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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