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Alkylating agents
Chemotherapy for Gastric Cancer
Phase 2
Waitlist Available
Led By Hatim Karachiwala, MD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically documented locally advanced or metastatic gastric or GEJ adenocarcinoma not previously treated with palliative systemic therapy
Patients with a performance status of ECOG 0-1 will be eligible for enrolment (see appendix 1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years from final study drug dose.
Awards & highlights
Study Summary
This trial will study if it is safe to give patients with stomach or gastroesophageal junction cancer who have not had prior treatment irinotecan, trifluridine/tipiracil, and oxaliplatin.
Who is the study for?
Adults with advanced gastric or gastroesophageal junction adenocarcinoma who haven't had palliative systemic therapy can join. They must be in good physical condition, not pregnant, willing to use birth control, and have recovered from any previous treatments. People with certain serious health conditions, other cancers within the last 5 years (except some treated skin or in-situ cancers), severe infections, significant heart issues within the past 6 months, pre-existing neuropathy grade 2 or higher, known hepatitis B/C or HIV infection cannot participate.Check my eligibility
What is being tested?
The trial is testing a combination of drugs: Irinotecan, Oxaliplatin and TAS-102 for patients who haven't received treatment before for their stomach cancer. It aims to see if this drug combo is safe and works as a first-line treatment option.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of the drugs such as nausea and fatigue; blood-related issues like low white cell count which could increase infection risk; nerve damage that might cause tingling sensations; liver function changes; and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My stomach cancer is advanced but hasn't been treated with systemic therapy yet.
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I am fully active or can carry out light work.
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I am using or willing to use effective birth control or practice abstinence during and 6 months after the study.
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I am 18 years old or older.
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I agree not to donate sperm during and for 6 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years from final study drug dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from final study drug dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility
Safety/Tolerability
Secondary outcome measures
Objective Response Rate
Overall Survival
Progression Free Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm iTTO treatmentExperimental Treatment3 Interventions
Patients will receive the combination of irinotecan, TAS-102, and Oxaliplatin on a 28 day cycle with the following doses;
Irinotecan 160mg/m2 IV infusion over 60-90 mins on day 1
Oxaliplatin 100mg/m2 IV infusion over 2 hours on day 1
TAS-102 (Trifluridine/Tipiracil) 25mg/m2 twice a day, on days 1-5 and 8-12 every 28days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Oxaliplatin
FDA approved
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,192 Total Patients Enrolled
Hatim Karachiwala, MDPrincipal InvestigatorAlberta Health Services - Cross Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My stomach cancer is advanced but hasn't been treated with systemic therapy yet.I do not have an ongoing infection that is getting worse despite treatment.I am fully active or can carry out light work.I have had bowel blockage or fluid buildup in my abdomen due to cancer spread.I have moderate to severe nerve damage from any cause.I do not have hepatitis B or C, HIV, and am not on drugs that weaken my immune system.I am able to understand and agree to the treatment plan.I am using or willing to use effective birth control or practice abstinence during and 6 months after the study.My blood, kidney, and liver tests meet the required levels for the trial.You have had an allergic reaction to the medications that will be used in the study.I am 18 years old or older.I have had radiation therapy to my pelvis or a significant part of my bone marrow.I have a history of lung scarring or fibrosis.I have had chemotherapy for advanced stomach or GEJ cancer.I have had cancer before, but it was either non-melanoma skin cancer, cervical, uterine, or low-grade prostate cancer treated over 6 months ago or any type treated over 5 years ago and considered cured.I haven't had a serious illness like a heart attack or uncontrolled diabetes in the last 6 months.I have a history of connective tissue disorders like lupus.I am not pregnant or breastfeeding, and if capable of childbearing, I have a recent negative pregnancy test and use effective contraception.My blood protein levels dropped by 20% or more recently.I am currently taking Coumadin.I am not breastfeeding or will stop before starting the treatment.I can follow the study's schedule and requirements without any issues.I do not have unstable brain metastases.My cancer is HER2 positive, or was found to be after joining the study.I had palliative radiotherapy over 4 weeks ago and have recovered from its side effects.I am a woman who can have children and have a negative pregnancy test.I agree not to donate sperm during and for 6 months after the study.I had surgery over 4 weeks ago and have recovered from its side effects.I have treated brain metastasis, am stable on steroids or off them, and my brain scans have been stable for 3 months.I completed my initial cancer treatment over 6 months ago.My cancer's HER2 status is either not tested, negative, or unknown.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm iTTO treatment
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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