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

Menoufia University

Status and phase: Enrolling; Phase 2

Conditions: Cancer of Pancreas

Treatments: Drug: Capecitabine; Other: follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT05566743

10001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

the maintenance arm

Experimental group

Description:

in this arm patients will receive 4 months of induction FOLFRINOX then maintenance capecitabine

Treatment:

Drug: Capecitabine

the control arm

Other group

Description:

in this arm patients will receive 4 months of FOLFRINOX then kept under follow-up

Treatment:

Other: follow up