A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Menoufia University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- PFS
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Histologically confirmed invasive adenocarcinoma of pancreas.
- •Stage 4 disease according to The American Joint Committee on Cancer (AJCC the 8th Edition)
- •Measurable metastases according to RECIST 1.
- •Patients underwent surgical resection and postoperative evaluation revealed distant metastasis.
- •Patients with age ranging from 18 to
- •WHO performance status 0-
- •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.
Arms & Interventions
the maintenance arm
in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine
Intervention: Capecitabine (Drug)
the control arm
in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up
Intervention: follow up (Other)
Outcomes
Primary Outcomes
PFS
Time Frame: 6 months
that will be calculated from the time of randomization till disease progression or death
Secondary Outcomes
- OS(1 year)
Investigators
Nahla Atef Shabaan
assistant lecturer of clinical oncology and nuclear medicine
Menoufia University