A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas

A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas

A randomized phase II study evaluating maintenance therapy after first line induction chemotherapy in metastatic cancer pancreas.

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.

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.