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

• Status: Recruiting
• Trial end date: 2024-09-11
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Menoufia University
• Treatments: Capecitabine

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.