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Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer

Study acronym: SPECTRA
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 13, 2023 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Jul 2024 to Jul 2025 Start date: Jul 2022 to Nov 2023 · Completion date: Jul 2029 to Jul 2030 · Site contact updatedv2 Show 3 more changesShow less
    • Start date: Jul 2022 to Nov 2023
    • Completion date: Jul 2029 to Jul 2030
    • Site contact updated
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis. Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile. Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease).
Trial Details
NCT Number NCT05318794
Lead Sponsor Imperial College London
Conditions Gastric Cancer, Peritoneal Metastases, Chemotherapy Effect
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov