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.

Study Overview

• Status: Recruiting
• Conditions: Cancer of Pancreas
• Intervention / Treatment: Drug: Capecitabine; Other: follow up

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nahla Atef Shabaan, Master; Phone Number: +2001099577494; Email: dr.nahla.atef@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12345
    • Recruiting
    • Egypt
    • Contact: Nahla Atef Shabaan, Master; Phone Number: +2001099577494; Email: dr.nahla.atef@gmail.com
  • Cairo, Egypt, 12345
    • Recruiting
    • Nahla Atef Shabaan
    • Contact: Nahla Atef Shabaan, Master; Phone Number: +2001099577494; Email: dr.nahla.atef@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Nahla Atef Shabaan, Master, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2022
• Primary Completion (Anticipated): September 11, 2023
• Study Completion (Anticipated): September 11, 2024

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neoplastic Processes; Pancreatic Diseases; Neoplasm Metastasis; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: 10001 (Disarm Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No