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

Primary Purpose

Cancer of Pancreas

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Capecitabine

follow up

About this trial

This is an interventional other trial for Cancer of Pancreas

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

EgyptRecruiting
Nahla Atef ShabaanRecruiting
Nahla Atef ShabaanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

the maintenance arm

the control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

PFS

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

Secondary Outcome Measures

that will be calculated from the time of starting of the disease to death (all causes)

Full Information

NCT ID

NCT05566743

First Posted

September 22, 2022

Last Updated

September 30, 2022

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT05566743

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 11, 2022 (Actual)

Primary Completion Date

September 11, 2023 (Anticipated)

Study Completion Date

September 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of Pancreas

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the maintenance arm

Arm Type

Experimental

Arm Description

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

Arm Title

the control arm

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

maintenance capecitabine after 4 months of FOLFRINOX

Intervention Type

Other

Intervention Name(s)

follow up

Intervention Description

follow up after 4 months of FOLFRINOX

Primary Outcome Measure Information:

Title

PFS

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Description

that will be calculated from the time of starting of the disease to death (all causes)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nahla Atef Shabaan, Master

Phone

+2001099577494

dr.nahla.atef@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nahla Atef Shabaan, Master

Organizational Affiliation

Menoufia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Egypt

City

Cairo

ZIP/Postal Code

12345

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nahla Atef Shabaan, Master

Phone

+2001099577494

dr.nahla.atef@gmail.com

Facility Name

Nahla Atef Shabaan

City

Cairo

ZIP/Postal Code

12345

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nahla A Shabaan

Phone

+2001099577494

dr.nahla.atef@gmail.com

First Name & Middle Initial & Last Name & Degree

Nahla Atef Shabaan, Master

First Name & Middle Initial & Last Name & Degree

Mohamed Abouelfetouh Shehata, M.D.

First Name & Middle Initial & Last Name & Degree

Alshimaa Mahmoud Alhanafy, M.D.

First Name & Middle Initial & Last Name & Degree

Mohamed Elsherbiny Hasan, M.D.

First Name & Middle Initial & Last Name & Degree

Amira Hosny Hegazay, M.D.

Facility Name

Nahla Atef Shabaan

City

Cairo

ZIP/Postal Code

12345

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nahla Atef Shabaan, Master

Phone

+2001099577494

dr.nahla.atef@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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