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Alkylating agents

Hyperthermic Intraperitoneal Chemotherapy for Stomach Cancer

Phase 2

Waitlist Available

Led By Brian D Badgwell

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing how well two chemotherapy drugs work when heated and infused directly into the stomach during surgery for stomach or gastroesophageal cancer.

Eligible Conditions

Stomach Cancer
Gastroesophageal Junction Adenocarcinoma
Peritoneal Carcinomatosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrent Brain Neoplasm

Secondary outcome measures

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (mitomycin, cisplatin)Experimental Treatment3 Interventions

Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Hyperthermic Intraperitoneal Chemotherapy

2010

Completed Phase 3

~210

Mitomycin

2009

Completed Phase 3

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,778 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,643 Total Patients Enrolled

Brian D BadgwellPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What conditions are typically treated through Hyperthermic Intraperitoneal Chemotherapy?

"Hyperthermic Intraperitoneal Chemotherapy is regularly applied to treat head and neck carcinoma, yet it may also be beneficial for managing cervical cancers, low-grade upper tract urothelial cancer (lg-utuc), and glaucoma."

Answered by AI

What is the regulatory status of Hyperthermic Intraperitoneal Chemotherapy?

"Due to the lack of efficacy data, Hyperthermic Intraperitoneal Chemotherapy was rated 2 on our scale from 1-3. However, there is evidence that suggests it can be safely administered in a clinical setting."

Answered by AI

Is the enrollment period for this experiment ongoing?

"Unfortunately, this trial is no longer actively recruiting. It was initially posted on September 1st 2016 and the latest update to its records was on April 12th 2022. Alternatively, those seeking trials may consider 3157 studies dedicated to peritoneal carcinomatosis or 774 clinical projects concerning Hyperthermic Intraperitoneal Chemotherapy that are presently searching for participants."

Answered by AI

Are there any preceding research studies that focused on Hyperthermic Intraperitoneal Chemotherapy?

"Currently, 774 clinical trials are examining the efficacy of Hyperthermic Intraperitoneal Chemotherapy; 296 of these studies have entered Phase 3. Although a bulk of research is based in Shanghai, there are an extensive 45181 sites across the world that offer this particular treatment."

Answered by AI

How many participants are actively involved in this trial?

"At present, this clinical trial is not seeking to enrol participants. It was first posted on September 1st 2016 and the most recent modifications were made on April 12th 2022. However, for those searching for alternative studies, there are currently 3157 trials actively recruiting peritoneal carcinomatosis patients and 774 Hyperthermic Intraperitoneal Chemotherapy research projects open to new participants."

Answered by AI

Recent research and studies

Annals of Surgical OncologyJournal

A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology

Badgwell, Brian, Naruhiko Ikoma, Mariela Blum Murphy, Xuemei Wang, Jeannelyn Estrella, Sinchita Roy-Chowdhuri, Prajnan Das, et al.. 2020. “A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology”. Annals of Surgical Oncology. Springer Science and Business Media LLC. doi:10.1245/s10434-020-08739-5.

clinicaltrials.govStudy

Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

2016. "Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02891447.