Clinical trial NCT05566743: A Study Evaluating Maintenance Therapy After First Line Chemotherapy in Metastatic Cancer Pancreas
Official title: A Randomized Phase II Study Evaluating Maintenance Therapy After First Line Induction Chemotherapy in Metastatic Cancer Pancreas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer of Pancreas
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: PFS
timeFrame: 6 months
Secondary outcomes:
measure: OS
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Egypt
city: Cairo
country: Egypt
facility: Nahla Atef Shabaan
city: Cairo
country: Egypt
facility: Nahla Atef Shabaan
Study officials:
affiliation: Menoufia University
name: Nahla Atef Shabaan, Master
role: PRINCIPAL_INVESTIGATOR
References: