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Trial Title:
A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas
NCT ID:
NCT05566743
Condition:
Cancer of Pancreas
Conditions: Official terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Single (Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
maintenance capecitabine after 4 months of FOLFRINOX
Arm group label:
the maintenance arm
Other name:
Xeloda
Intervention type:
Other
Intervention name:
follow up
Description:
follow up after 4 months of FOLFRINOX
Arm group label:
the control arm
Summary:
A randomized phase II study evaluating maintenance therapy after first line induction
chemotherapy in metastatic cancer pancreas.
Detailed description:
In this study, we aim to evaluate the role of maintenance capecitabine by comparing 2
arms of metastatic cancer pancreas patients in the first line , the first arm will
receive 4 months of induction FOLFRINOX the maintenance capecitabine and the second arm
will receive 4 months of FOLFRINOX then kept under follow-up:
•Primary end point: PFS.
•Secondary end points: OS, QOL and Toxicity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed invasive adenocarcinoma of pancreas.
- Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th
Edition) 2017.
- Measurable metastases according to RECIST 1.1.
- Patients underwent surgical resection and postoperative evaluation revealed distant
metastasis.
- Patients with age ranging from 18 to 69.
- WHO performance status 0-1.
- An adequate bone marrow reserve and adequate liver and renal function as follow:
Neutrophils ≥ 1500 cell/dl, Platelets ≥ 100,000 cell/dl, Hemoglobin ≥ 9.0 g/dl,
Total bilirubin < 1.5 × upper normal level (UNL), SGOT and SGPT < 3 × UNL,
Creatinine < 1.5 × UNL or estimated GFR > 30 ml/min.
- Adjuvant and neoadjuvant chemotherapies will be permitted if administered more than
6 months before inclusion.
- Patients with biliary or gastroduodenal obstruction must have drainage or surgical
bypass prior to starting chemotherapy.
- All patients must have signed and dated informed consent form.
Exclusion Criteria:
- Endocrine or acinar pancreatic carcinoma.
- Patients who progressed during FOLFRINOX regimen.
- Pregnancy or breast feeding.
- Patients with complicated systemic diseases such as diabetes, HTN or decompensated
liver disease.
- Patients with any serious uncontrolled medical conditions that might compromise
study participation: Central nervous system disorders, gastrointestinal tract
disorders that interfere with oral medication.
- Patients with history of previous other carcinoma except basal cell carcinoma of the
skin, insitu cervical carcinoma or non-metastatic prostate cancer.
- More than grade 1 peripheral neuropathy.
- Brain metastasis.
Gender:
All
Minimum age:
18 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Egypt
Address:
City:
Cairo
Zip:
12345
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nahla Atef Shabaan, Master
Phone:
+2001099577494
Email:
dr.nahla.atef@gmail.com
Facility:
Name:
Nahla Atef Shabaan
Address:
City:
Cairo
Zip:
12345
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nahla A Shabaan
Phone:
+2001099577494
Email:
dr.nahla.atef@gmail.com
Investigator:
Last name:
Nahla Atef Shabaan, Master
Email:
Principal Investigator
Investigator:
Last name:
Mohamed Abouelfetouh Shehata, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Alshimaa Mahmoud Alhanafy, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mohamed Elsherbiny Hasan, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Amira Hosny Hegazay, M.D.
Email:
Sub-Investigator
Facility:
Name:
Nahla Atef Shabaan
Address:
City:
Cairo
Zip:
12345
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Nahla Atef Shabaan, Master
Phone:
+2001099577494
Email:
dr.nahla.atef@gmail.com
Start date:
September 11, 2022
Completion date:
September 11, 2024
Lead sponsor:
Agency:
Menoufia University
Agency class:
Other
Source:
Menoufia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566743
