22 Participants NeededMy employer runs this trial

Chemotherapy for Stomach Cancer

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CS
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Overseen ByStacy Cole, RN, BSN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mohammad Haroon Asif Choudry
Must be taking: Systemic chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special type of chemotherapy called hyperthermic intraperitoneal chemotherapy (HIPEC) for individuals with advanced stomach cancer that has spread to the abdominal area. It combines two drugs, cisplatin and mitomycin C, which are heated and applied directly inside the abdomen to target cancer cells more effectively. Individuals with stomach cancer showing signs of spreading in the abdomen and who have completed 4-6 months of regular chemotherapy might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in cancer treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since participants must have completed 4-6 months of systemic therapy before enrolling, it's possible that some medications may need to be adjusted. Please consult with the trial coordinators for specific guidance.

What prior data suggests that this chemotherapy protocol is safe for stomach cancer patients?

Earlier studies have examined the safety and effectiveness of using cisplatin and mitomycin C in hyperthermic intraperitoneal chemotherapy (HIPEC). Research shows that patients generally tolerate this treatment well, with most managing side effects without major issues. Common side effects include nausea, fatigue, and low blood cell counts, which can usually be managed with standard care.

More detailed information indicates that the safety profile of this treatment remains consistent across different studies. For instance, one study found that patients receiving cisplatin and mitomycin C HIPEC did not experience any unexpected severe side effects, suggesting the treatment is relatively safe for individuals with advanced stomach cancer.

While these findings are encouraging, they are based on past research. It's crucial to discuss with a doctor how these treatments might affect an individual personally.12345

Why are researchers excited about this trial's treatments for stomach cancer?

Unlike the standard treatments for stomach cancer, which typically involve systemic chemotherapy, this investigational treatment utilizes hyperthermic intraperitoneal chemotherapy (HIPEC). HIPEC delivers chemotherapy directly to the abdominal cavity, allowing for higher concentrations of cisplatin and mitomycin C to target cancer cells more effectively. By heating the chemotherapy solution to 42°C, it enhances drug absorption and distribution within the abdomen. Researchers are excited about this technique because it aims to maximize the impact on cancer cells while potentially reducing the systemic side effects commonly seen with traditional chemotherapy.

What evidence suggests that this trial's treatments could be effective for stomach cancer?

This trial will evaluate hyperthermic intraperitoneal chemotherapy (HIPEC) for stomach cancer. Studies have shown that combining cisplatin and mitomycin C in HIPEC may extend the lives of patients with stomach cancer that has spread to the abdomen. Research indicates that this treatment can prolong life, with one study showing an average survival time of 16.4 months. Another study found that HIPEC increases the chances of surviving for 3 and 5 years compared to surgery alone. Additionally, this treatment can help delay cancer progression. These findings suggest that cisplatin and mitomycin C HIPEC could be a promising option for treating stomach cancer that has spread to the abdomen.25678

Who Is on the Research Team?

HC

Haroon Choudry, MBBS, FACS

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced stomach or gastroesophageal cancer that has spread to the lining of the abdomen. Participants must have completed 4-6 months of chemotherapy, be in generally good health, not pregnant or breastfeeding, and able to consent. Certain genetic tumor types and other serious illnesses are excluded.

Inclusion Criteria

I can care for myself, and any weakness is only due to my gastric cancer.
Patient should have a life expectancy of >6 months
Sexually active fertile subjects and their partners must agree to use highly effective method of contraception
See 8 more

Exclusion Criteria

I have had abdominal surgeries that make laparoscopic procedures unsafe for me.
I have fluid buildup in my abdomen that needs frequent draining.
My tumor has one of several specific genetic or protein markers.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive systemic chemotherapy every two weeks and laparoscopic HIPEC every 6 weeks, with a maximum of 3 HIPEC procedures

18 weeks
Biweekly visits for systemic chemotherapy, every 6 weeks for HIPEC

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin
  • Mitomycin C

Trial Overview

The study tests adding heated chemotherapy directly into the abdomen (HIPEC) using cisplatin and mitomycin C during surgery, along with standard intravenous chemotherapy. The goal is to see if this combined approach helps patients more than standard treatment alone.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Hyperthermic intraperitoneal chemotherapy (HIPEC)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mohammad Haroon Asif Choudry

Lead Sponsor

Dr. Samer AlMasri, MD

Collaborator

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/21431408/

final results of a phase III randomized clinical trial

Conclusions: For synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity. Publication ...

Final Results of a Phase III Randomized Clinical Trial - PMC

Conclusions. For synchronous gastric PC, CRS + HIPEC with mitomycin C 30 mg and cisplatin 120 mg may improve survival with acceptable morbidity.

Adjuvant Hyperthermic Intraperitoneal Chemotherapy for ...

The purpose of this study is to determine safety and feasibility of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin and cisplatin in ...

Effect of Hyperthermic Intraperitoneal Chemotherapy on ...

This study showed no OS difference between CRS + H and CRS-A. PFS and MFS were significantly better in the CRS + H group, which needs further exploration.

Prolonged hyperthermic intraperitoneal chemotherapy ...

Prolonged hyperthermic intraperitoneal chemotherapy duration with 90 minutes cisplatin might increase overall survival in gastric cancer ...

Indication of Hyperthermic Intraperitoneal Chemotherapy in ...

Intraperitoneal chemotherapy seems to improve the prognosis of patients with GC and peritoneal metastasis after complete resection of both primary and ...

Selection of chemotherapy for hyperthermic intraperitoneal ...

Several studies have shown the potential benefit of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in gastric cancer ...

Outcomes of intraperitoneal chemotherapy for the ...

Outcomes of intraperitoneal chemotherapy for the treatment of gastric cancer with peritoneal metastasis: A comprehensive systematic review and meta-analysis.