iTTo for Treatment Naive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Sponsor
AHS Cancer Control Alberta
Study ID
NCT04808791
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Gastric Carcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase I inhibitor."
  • Oxaliplatin — DRUG
    Oxaliplatin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Oxaliplatin is classified as an "alkylating agent."
  • TAS 102 (Trifluridine/Tipiracil) — DRUG
    Trifluridine/Tipiracil is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as an antimetabolite/pyrimidine analog; antimetabolite/thymidine phosphorylase inhibitor

Study Details

This study will evaluate the safety and feasibility of Irinotecan, Trifluridine/Tipiracil (TAS-102) and Oxaliplatin (iTTo) for treatment naïve advanced gastric or gastroesophageal junction adenocarcinoma.

Key Dates

Start date
Oct 27, 2021
Status verified
Jun 2024
Primary completion
Jul 7, 2023
Completion
Jul 21, 2023

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm iTTO treatment
    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.

Primary Outcome Measure

The number of participants who complete at least 2 cycles of iTTo for the treatment of advanced gastric and GEJ cancers, over the total duration of study [ Time Frame: 1 year after enrolment of last participant. ]

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