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

Cancer of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566743
• Other study ID #: 10001
• Status: Recruiting
• Phase: Phase 2
• Start date: September 11, 2022
• Est. completion date: September 11, 2024

Study information

• Verified date: September 2022
• Source: Menoufia University
• Contact: Nahla Atef Shabaan, Master
• Phone: +2001099577494
• Email: dr.nahla.atef[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 11, 2024
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Neoplasm Metastasis
• Pancreatic Neoplasms

Intervention

Drug:
• Capecitabine
maintenance capecitabine after 4 months of FOLFRINOX

Other:
• follow up
follow up after 4 months of FOLFRINOX

Locations

Country	Name	City	State
Egypt	Egypt	Cairo
Egypt	Nahla Atef Shabaan	Cairo
Egypt	Nahla Atef Shabaan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	that will be calculated from the time of randomization till disease progression or death	6 months
Secondary	OS	that will be calculated from the time of starting of the disease to death (all causes)	1 year