Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Neoplasms

1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Peritoneal Neoplasms+5 More
Hyperthermic Intraperitoneal Chemotherapy - Drug
Eligibility
18+
All Sexes
Eligible conditions
Peritoneal Neoplasms

Study Summary

This study is evaluating whether heated mitomycin and cisplatin during surgery works better than heated placebo during surgery in treating patients with stomach or gastroesophageal cancer.

See full description

Eligible Conditions

  • Peritoneal Neoplasms
  • Adenocarcinoma
  • Carcinoma
  • Adenocarcinomas of the Gastroesophageal Junction
  • Adenocarcinoma of the Stomach
  • Peritoneal Carcinomatosis

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Hyperthermic Intraperitoneal Chemotherapy will improve 1 primary outcome and 1 secondary outcome in patients with Peritoneal Neoplasms. Measurement will happen over the course of From the time of surgery up to 5 years.

Year 5
Overall survival
Up to 5 years
Patterns of tumor recurrence

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (mitomycin, cisplatin)

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 different treatments. Hyperthermic Intraperitoneal Chemotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (mitomycin, cisplatin)Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mitomycin
FDA approved
Chloride ion
Not yet FDA approved
Hyperthermic Intraperitoneal Chemotherapy
2010
Completed Phase 3
~190

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient's serum creatinine is less than 1.5 milligrams per deciliter. show original
An abnormal number of cancerous tumors were found in the patient's abdomen during a diagnostic laparoscopy or laparotomy. show original
Eastern Cooperative Oncology Group (ECOG) performance status = 0 A person who is in good health with no symptoms is said to have a performance status of 0 show original
A blood test result of "absolute neutrophil count >= 1,500/uL" means that the person's neutrophil count is greater than or equal to 1,500/uL. show original
Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
Leukocytes >= 3,000/uL
Platelets >= 60,000/Ul
Positive peritoneal cytology
for appendiceal mucinous adenocarcinoma The patient underwent preoperative systemic chemotherapy and preoperative laparoscopic HIPEC for appendiceal mucinous adenocarcinoma. show original

Patient Q&A Section

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

What are the signs of peritoneal neoplasms?

Add answer

Peritoneal masses can present with a number of signs, some of which may be the presenting signs of malignancy, such as nausea, vomiting, or ascites.

Unverified Answer

How many people get peritoneal neoplasms a year in the United States?

Add answer

Peritoneal neoplasms are the most common malignancy seen in US veterans. Nearly all veterans with peritoneal neoplasms develop them after Vietnam. Almost 80% of patients with peritoneal neoplasms develop these cancers as a primary cancer.

Unverified Answer

What are common treatments for peritoneal neoplasms?

Add answer

For treatment of ascites, transcatheter venous interventions are often used for drainage, including catheters, transhepatic venous catheters, and percaval stents. Transjugular intrahepatic portosystemic shunt, the hepatic-renal shunt, and the Shunt for the portal vein to the common bile duct, are now being used less frequently. For neoplasm of the bile duct, surgery is typically indicated in cases with malignant progression. Shunt procedures are also used in case of neovascularization with bleeding from the portal veins.

Unverified Answer

Can peritoneal neoplasms be cured?

Add answer

The present data may show that an alternative way of looking at the outcome of patients with peritoneal neoplasms as opposed to just cure is more useful and is required.

Unverified Answer

What is peritoneal neoplasms?

Add answer

The mean lifespan was 12 years; the median time in care was 11.1. In 10% of cases, the primary tumor was localized. A large portion of patients had metastatic disease at the time of death, with the main locations being lung and liver. The most common histologic type was adenocarcinoma (62%), which was the most common primary tumor localization, accounting for 58% of neoplasms. A large proportion displayed clear cytology at diagnosis (55%). There was much more favorable survival when a surgical procedure was used to treat the tumor (81% vs 37%; p = 0.02).

Unverified Answer

What causes peritoneal neoplasms?

Add answer

Peritoneal neoplasms were more common in women and with adenocarcinoma, but their occurrence had no obvious relation to specific factors. Pneumocystis infection and carcinomatosis were rare.

Unverified Answer

How serious can peritoneal neoplasms be?

Add answer

Most patients with a peritoneal neoplasm die of the cancer. Patients with a good performance status and asymptomatic or low tumours had similar mortality patterns with less than 5% of the patients reaching the 5 year follow up. Longer term survivors were those with a higher performance status, an asymptomatic tumour, and with tumours < 20mm in size. Peritoneal cancer patients with low performance status, significant pain, anaemia, and a tumour greater than 15mm may have a poorer prognosis compared to age- and stage dependent cohorts.

Unverified Answer

Is hyperthermic intraperitoneal chemotherapy safe for people?

Add answer

Patients recovering from cancer who are treated with chemotherapy have an increased risk of peritoneal-based sepsis, bleeding, abscess, and nephrotoxicity and a decreased risk of GI and GV complications compared with patients undergoing other treatments.

Unverified Answer

Has hyperthermic intraperitoneal chemotherapy proven to be more effective than a placebo?

Add answer

We demonstrated that hyperthermic intraperitoneal chemotherapy with oxaliplatin was superior to a placebo. Hyperthermic intraperitoneal chemotherapy with oxaliplatin proved to be effective and safe in the treatment of colorectal carcinoma peritoneal metastases, without significant side-effects.

Unverified Answer

What is the primary cause of peritoneal neoplasms?

Add answer

There is a high prevalence of neoplasia on peritoneum in patients with PEL. For patients with PEL, the main cause was not peritoneal cancer (16.5%) but rather ascites due to the development of peritoneal neoplasms or as a side effect of peritoneal dialyses. Other causes were bowel obstruction or peritoneal tumor spillage.

Unverified Answer

What is the latest research for peritoneal neoplasms?

Add answer

[The newest research, which has a higher level of efficacy and lower drug adverse reactions, is an anti-vascular therapy based on gemcitabine: an effective therapy for peritoneal neoplasms in selected patients. This article describes the latest research and clinical status of peritoneal neoplasms in recent years. (http://www.ncbi.nlm.nih.gov/pubmed/) (https://en.hsa.gov/healthcare/clinicaltrials/trialstatus.aspx?Id=46).

Unverified Answer

What are the common side effects of hyperthermic intraperitoneal chemotherapy?

Add answer

Common side effects (>10% of patients):\n1. Rash\n2. Hypersensitivity (allergy, allergy-type reactions)\n3. Fatigue/mood disturbance (depression, irritability)\n4. Diarrhea\n5. Nausea/vomiting\n6. Seizures (epilepsy)\n7. Fever ( fever of >38°C ) (> 39 °C)\n8.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Peritoneal Neoplasms by sharing your contact details with the study coordinator.