Last reviewed · How we verify

NCT02092298

Laparoscopic Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) for Metastatic Gastric Cancer

Completed Phase 2 Results posted Last updated 15 June 2021
What this trial tests

Phase 2 trial testing Mitomycin C in Gastrointestinal Cancer in 21 participants. Completed in 12 May 2020.

Timeline
8 May 2014
Primary endpoint
12 May 2020
12 May 2020

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date8 May 2014
Primary completion12 May 2020
Estimated completion12 May 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Gastrointestinal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Survival (OS) After Hyperthermic Intraperitoneal Chemotherapy Primary · Between the second and sixth week after treatment, up to 5 years

Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after laparoscopic hyperthermic intraperitoneal chemotherapy administration. Overall survival measured from time of laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.

GroupValue95% CI
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)30.2± 18.3
Overall Survival (OS) From the First Laparoscopic HIPEC Primary · From the day of surgery, until the last day of follow up, until death, up to 5 years

Primary objective of study is to assess overall survival (OS) in subjects with stage IV gastric cancer representing positive cytology or imaging occult carcinomatosis after the first laparoscopic HIPEC. Patterns of tumor recurrence and survival assessed by reviewing routine surveillance CT scans. Overall survival time estimated using the Kaplan-Meier method.

GroupValue95% CI
Hyperthermic Intraperitoneal Chemotherapy (HIPEC)20.3± 7.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious and Other (Not Including Serious Adverse Events) for 30 days and All-Cause Mortality for 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Serious: 0/19 (0%)
Deaths: 18/19
Other adverse events (4 terms — click to expand)

ReactionSystemHyperthermic Intraperitone…
ArrythmiaCardiac disorders
Kidney dysfunctionRenal and urinary disorders
Lung InjuryRespiratory, thoracic and mediastinal disorders
Blood ClotBlood and lymphatic system disorders

Data from ClinicalTrials.gov NCT02092298 adverse events section.

Sponsor's own description

The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to control the disease in patients with Stage 4 stomach or gastroesophageal cancer. The safety of this treatment will also be studied.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Photodynamic Therapy and Hyperthermia in Combination Treatment-Neglected Forces in the Fight against Cancer.
    Bienia A, Wiecheć-Cudak O, Murzyn AA, Krzykawska-Serda M. · · 2021 · cited 36× · PMID 34452108 · DOI 10.3390/pharmaceutics13081147
  2. Factors Associated with Resection and Survival After Laparoscopic HIPEC for Peritoneal Gastric Cancer Metastasis.
    White MG, Kothari A, Ikoma N, Murphy MB, et al · · 2020 · cited 17× · PMID 32648181 · DOI 10.1245/s10434-020-08842-7
  3. Laparoscopic HIPEC for Low-Volume Peritoneal Metastasis in Gastric and Gastroesophageal Adenocarcinoma.
    Blumenthaler AN, Allen CJ, Ikoma N, Blum M, et al · · 2020 · cited 16× · PMID 32737700 · DOI 10.1245/s10434-020-08968-8
  4. Lessons learned from a phase II clinical trial of laparoscopic HIPEC for gastric cancer.
    Badgwell B, Blum M, Das P, Estrella J, et al · · 2018 · cited 13× · PMID 28643069 · DOI 10.1007/s00464-017-5668-9
  5. Current Evidence for the Use of HIPEC and Cytoreductive Surgery in Gastric Cancer Metastatic to the Peritoneum.
    Jain AJ, Badgwell BD. · · 2023 · cited 11× · PMID 37892663 · DOI 10.3390/jcm12206527
  6. ISSPP 2021 2nd Congress of the International Society for the Study of Pleura and Peritoneum.
    Kugel J. · · 2021 · cited 5× · PMID 34676288 · DOI 10.1515/pp-2021-0141

Verify or expand the search:

Other trials of Mitomycin C

Trials testing the same drug.

Other recruiting trials for Gastrointestinal Cancer

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02092298.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing