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

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

Detailed Description
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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.

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

Conditions
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Cancer of Pancreas

Intervention / Treatment
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* Drug: Capecitabine
* Other: follow up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the maintenance arm<br>in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine | Drug: Capecitabine<br>* maintenance capecitabine after 4 months of FOLFRINOX<br>* Other names: Xeloda;|
| Other: the control arm<br>in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up | Other: follow up<br>* follow up after 4 months of FOLFRINOX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | that will be calculated from the time of randomization till disease progression or death | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | that will be calculated from the time of starting of the disease to death (all causes) | 1 year |