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FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma (LOGIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528876
Recruitment Status : Suspended (Need Health Canada approval)
First Posted : May 18, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Shahid Ahmed, University of Saskatchewan

Brief Summary:

Background: Gastro-esophageal (GE) cancers are a highly aggressive disease and are one of the major causes of cancer-related death worldwide. In general, combination chemotherapy has been associated with better outcomes compared with single agent chemotherapy. Fluoropyrimidine doublets FOLFOX (infusional 5FU and oxaliplatin) or FOLFIRI (infusional 5FU and irinotecan) are some of the standard first-line regimens and are less toxic than the anthracycline containing three drug regimen. Although platinum compounds are very effective in GE cancers, patients who are treated with platinum-based therapy often develop severe neuropathy and may not be able to tolerate a salvage second-line paclitaxel-based therapy.

Objectives: To evaluate progression free survival, time to progression, overall survival, toxicity and quality of life in previously untreated patients with metastatic GE cancers who will be treated with a novel biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI. To determine the correlation between various clinical and pathological biomarkers including an early FDG-PET scan response and patient outcomes.

Design: Phase 2 clinical trial Methods: Thirty-six adult patients with histologically proven HER2 negative metastatic adenocarcinomas or poorly differentiated GE cancers will be recruited at the two major cancer centers in Saskatchewan over a period of two years. Patients will receive chemotherapy every two weeks and will undergo periodic imaging studies every 8 weeks. A Cox proportional analysis will be performed to assess various clinical and pathologic factors including an early FDG-PET/CT response and their correlation with patient outcomes.

Significance: The LOGIC study aims to develop an effective but potentially less toxic regimen in the management of metastatic GE cancers, offering the possibility of longer disease control as a result of 100% exposure to two active doublets in a first-line treatment setting with lower neurotoxicities and an improved rate of salvage second-line therapy. This study will inform the care of patients with metastatic GE cancers and will be used to design a larger phase 3 trial to establish a more effective but less toxic chemotherapy regimen for patients with metastatic GE cancer and to establish role of FDG-PET/CT scan and other biomarkers in predicting outcomes.


Condition or disease Intervention/treatment Phase
Metastatic Gastro-esophageal Adenocarcinoma Drug: FOLFOX and FOLFIRI Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma. The LOGIC Study
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Single arm intervention study
Biweekly FOLFOX for two cycles alternating with FOLFIRI for two cycles (FOLFOX-FOLFIRI)
Drug: FOLFOX and FOLFIRI
a biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI.




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: At 12 months ]
    Time from enrollment till the date of disease progression


Secondary Outcome Measures :
  1. overall survival [ Time Frame: At 3 years ]
    Time from enrollment till death from any cause

  2. Metabolic response rate [ Time Frame: At 2 months ]
    change in baseline SUV of PET-CT after 4 cycles of chemotherapy

  3. Neurotpathy [ Time Frame: At 6 and 12 months ]
    grade 3/4 neuropathy

  4. Decline in quality of life [ Time Frame: At 6 and 12 months ]
    The European Organization for Research and the Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) along with the EORTC Esophago-Gastric Cancer Module (QLQ-OG25).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (≥18 years older) with histologically proven HER2 negative adenocarcinoma or poorly differentiated carcinoma of the esophagus, GE junction tumors, and gastric cancer.
  • Measurable or assessable metastatic disease.
  • Performance status World Health Organization (WHO) 0-2 and life expectancy of greater than 3 months.
  • No previous chemotherapy for advanced disease.
  • Adequate functioning of the bone marrow, liver, and kidneys.

Exclusion Criteria:

  • Breastfeeding or pregnancy.
  • Active second primary cancer except in situ cancer or non-melanoma skin cancer.
  • Cerebral metastases or leptomeningeal carcinomatosis.
  • Severe or uncompensated concomitant medical conditions including peripheral neuropathy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528876


Locations
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Canada, Saskatchewan
Allan Blair Cancer Center
Regina, Saskatchewan, Canada, S4T7T1
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada, S7N4H4
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Shahid Ahmed, Md, PhD University of Saskatchewan
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Responsible Party: Shahid Ahmed, MD, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03528876    
Other Study ID Numbers: 99183
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shahid Ahmed, University of Saskatchewan:
gastric cancer
esophageal cancer
adnocarcinoma
FOLFIRI
FOLFOX
Metastatic cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases