NCT05566743

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2024

Completed
Last Updated

October 4, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 22, 2022

Last Update Submit

September 30, 2022

Conditions

Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

  • PFS

    that will be calculated from the time of randomization till disease progression or death

    6 months

Secondary Outcomes (1)

  • OS

    1 year

Study Arms (2)

the maintenance arm

EXPERIMENTAL

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

Drug: Capecitabine

the control arm

OTHER

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

Other: follow up

Interventions

CapecitabineDRUG

maintenance capecitabine after 4 months of FOLFRINOX

Also known as: Xeloda
the maintenance arm
follow upOTHER

follow up after 4 months of FOLFRINOX

the control arm

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Egypt

Cairo, 12345, Egypt

RECRUITING

Nahla Atef Shabaan

Cairo, 12345, Egypt

RECRUITING

Nahla Atef Shabaan

Cairo, 12345, Egypt

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Nahla Atef Shabaan, Master

    Menoufia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nahla Atef Shabaan, Master

CONTACT

+2001099577494dr.nahla.atef@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer of clinical oncology and nuclear medicine

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 4, 2022

Study Start

September 11, 2022

Primary Completion

September 11, 2023

Study Completion

September 11, 2024

Last Updated

October 4, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(3)