FOLFIRI Alternate With FOLFOX in Untreated Metastatic Gastric and Esophageal Adenocarcinoma (LOGIC)
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|ClinicalTrials.gov Identifier: NCT03528876|
Recruitment Status : Suspended (Need Health Canada approval)
First Posted : May 18, 2018
Last Update Posted : July 24, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Progression free survival [ Time Frame: At 12 months ]Time from enrollment till the date of disease progression
- overall survival [ Time Frame: At 3 years ]Time from enrollment till death from any cause
- Metabolic response rate [ Time Frame: At 2 months ]change in baseline SUV of PET-CT after 4 cycles of chemotherapy
- Neurotpathy [ Time Frame: At 6 and 12 months ]grade 3/4 neuropathy
- 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).
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
|Allan Blair Cancer Center|
|Regina, Saskatchewan, Canada, S4T7T1|
|Saskatoon Cancer Center|
|Saskatoon, Saskatchewan, Canada, S7N4H4|
|Principal Investigator:||Shahid Ahmed, Md, PhD||University of Saskatchewan|