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Maintenance Therapy in Metastatic Gastric Cancer: A Multicenter Retrospective Study in Colombia

ConditionsStomach NeoplasmsGastric AdenocarcinomaMetastatic Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación Santa Fe de Bogota

About this trial

Metastatic gastric cancer has a poor prognosis, and the cumulative toxicity of first-line platinum and fluoropyrimidine chemotherapy limits how long treatment can be continued. Maintenance therapy, in which patients whose disease is at least stable after induction chemotherapy continue on a less toxic regimen, is increasingly used, most often with fluoropyrimidines (capecitabine, 5-fluorouracil or S-1) and, in selected molecular subgroups, with immunotherapy or targeted therapy. Evidence on the outcomes of these strategies in Latin American patients is scarce.

This multicenter retrospective study will review the medical records of adults with metastatic gastric cancer treated between 2013 and 2023 at four high-complexity cancer centers in Bogotá, Colombia, who received maintenance therapy after achieving at least stable disease with induction chemotherapy. The study will describe the demographic, clinical, pathological and molecular characteristics of these patients and estimate overall survival, progression-free survival, treatment response, toxicity and mortality. The investigators will not assign or modify any treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years diagnosed with metastatic gastric cancer at a participating institution between 2013 and 2023 who received fluoropyrimidines, immunotherapy or targeted therapy as maintenance therapy.

At least stable disease according to RECIST criteria after initial induction treatment, with ECOG performance status of 2 or less, followed by maintenance therapy with fluoropyrimidines.

Medical record showing institutional oncology follow-up.

Disqualifiers

Biopsies that do not meet the quality and adequacy criteria required for analysis.

No clinical or imaging follow-up at the institution after diagnosis and treatment.

Metastatic gastric cancer treated exclusively with palliative care without fluoropyrimidine maintenance chemotherapy.

Discontinuation of fluoropyrimidine maintenance therapy before the first follow-up assessment because of toxicity or medical decision, without evaluation of treatment response.

Trial population

Adults with metastatic gastric cancer diagnosed and treated between 2013 and 2023 at four high-complexity cancer centers in Bogotá, Colombia (Hospital Universitario Fundación Santa Fe de Bogotá, Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Clínica del Country and Los Cobos Medical Center) who received maintenance therapy after achieving at least stable disease with induction chemotherapy.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Fluoropyrimidine Maintenance Therapy

    Drug

    Fluoropyrimidine-based maintenance therapy (capecitabine, 5-fluorouracil or S-1) administered after induction chemotherapy in routine clinical practice. The study does not assign or modify treatment; exposure data are abstracted retrospectively from medical records.

  • Immune Checkpoint Inhibitor Maintenance

    Drug

    Immune checkpoint inhibitors (such as nivolumab, pembrolizumab or atezolizumab) administered as part of maintenance therapy in routine clinical practice. The study does not assign or modify treatment.

  • Targeted Therapy Maintenance

    Drug

    Targeted therapy (such as trastuzumab in HER2-positive disease) administered as part of maintenance therapy in routine clinical practice. The study does not assign or modify treatment.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Maintenance Therapy Cohort3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival

Time frame
From start of maintenance therapy until death from any cause or last follow-up, assessed up to 10 years

Secondary outcomes

1

Progression-Free Survival

Time frame
From start of maintenance therapy until disease progression, death or last follow-up, assessed up to 10 years
2

Best Response to Maintenance Therapy

Time frame
From start of maintenance therapy until disease progression or end of maintenance, assessed up to 10 years
3

Survival Rate at 6 Months and 1, 2, 3, 4 and 5 Years

Time frame
6 months and 1, 2, 3, 4 and 5 years after diagnosis
4

Number of Patients With Adverse Drug Reactions During Maintenance Therapy

Time frame
From start of maintenance therapy until end of maintenance, assessed up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Santa Fe de Bogota

Lead sponsor

Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

Collaborator

Clínica del country

Collaborator

Source ClinicalTrials.gov
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