A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas
Study Details
Study Description
Brief Summary
A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: the maintenance arm in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine |
Drug: Capecitabine
maintenance capecitabine after 4 months of FOLFRINOX
Other Names:
|
| Other: the control arm in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up |
Other: follow up
follow up after 4 months of FOLFRINOX
|
Outcome Measures
Primary Outcome Measures
- PFS [6 months]
that will be calculated from the time of randomization till disease progression or death
Secondary Outcome Measures
- OS [1 year]
that will be calculated from the time of starting of the disease to death (all causes)
Eligibility Criteria
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Egypt | Cairo | Egypt | 12345 | |
| 2 | Nahla Atef Shabaan | Cairo | Egypt | 12345 | |
| 3 | Nahla Atef Shabaan | Cairo | Egypt | 12345 |
Sponsors and Collaborators
- Menoufia University
Investigators
- Principal Investigator: Nahla Atef Shabaan, Master, Menoufia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 10001