Heated Chemotherapy for Gastric Cancer

CT
Overseen ByClinical Trials Referral Office
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 new method to treat stomach cancer by applying heated chemotherapy directly to the abdominal area during surgery. The researchers aim to determine if this approach can prevent cancer from returning in the abdomen post-surgery. Participants will receive a combination of two chemotherapy drugs, cisplatin and paclitaxel, which are heated and circulated in the abdomen. This trial may suit individuals with stomach or gastroesophageal junction cancer at high risk of recurrence in the abdominal area. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important research.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to understand how your medications might interact with the trial treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using heated chemotherapy directly in the abdomen is generally safe for patients with stomach cancer. This method, called hyperthermic intraperitoneal chemotherapy (HIPEC), involves using heated drugs, cisplatin and paclitaxel, during surgery. Studies have found that HIPEC is safe and well-tolerated, especially for patients with advanced stomach cancer. One study showed that patients treated with HIPEC had better survival rates compared to those who received traditional treatments.

Cisplatin and paclitaxel are drugs known to work well against stomach tumors. While administering these drugs to the whole body hasn't been effective for cancer that has spread in the abdomen, HIPEC targets the treatment directly where it's needed.

Overall, evidence suggests that this treatment can be safely administered during surgery and may help reduce the chance of cancer recurrence in the abdomen.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the heated chemotherapy treatment for gastric cancer because it combines standard chemotherapy drugs, cisplatin and paclitaxel, with a unique delivery method known as p-HIPEC (pressurized intraperitoneal aerosol chemotherapy). Unlike traditional treatments that administer chemotherapy systemically, this method delivers heated chemotherapy directly into the abdominal cavity. This approach allows for higher concentrations of the drugs to target cancer cells more effectively while potentially reducing systemic side effects. Additionally, the heat enhances the drugs' ability to penetrate and destroy cancer cells, making this treatment a promising alternative for patients with gastric cancer.

What evidence suggests that hyperthermic intraperitoneal chemotherapy might be an effective treatment for gastric cancer?

In this trial, participants will receive heated chemotherapy in the belly area during surgery, a method known as hyperthermic intraperitoneal chemotherapy (HIPEC). Studies have shown that using HIPEC with surgery can extend the time people with certain types of stomach cancer live without the cancer returning. One study improved survival rates to as long as 27.7 months. In this trial, HIPEC will be combined with the drugs cisplatin and paclitaxel, which research suggests can reduce the chances of cancer returning in the abdomen. Overall, HIPEC shows promise in treating stomach cancer, especially for those at high risk of recurrence.26789

Who Is on the Research Team?

TE

Travis E. Grotz, MD, MS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with gastric or gastroesophageal junction adenocarcinoma at high risk of cancer returning in the abdominal area after initial improvement. Eligibility details are not fully provided, but typically include factors like specific medical history and current health status.

Inclusion Criteria

Absolute neutrophil count (ANC) ≥ 1000/mm^3
Hemoglobin ≥ 8.0 g/dL
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
See 9 more

Exclusion Criteria

Nursing persons
Pregnant persons
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Patients undergo gastrectomy with reconstruction and D2 lymphadenectomy, and receive p-HIPEC with cisplatin and paclitaxel intraperitoneal over 90 minutes

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood sample collection and imaging

18 months
Multiple visits (in-person and virtual)

Long-term Follow-up

Participants are followed for recurrence-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin
  • Hyperthermic Intraperitoneal Chemotherapy
  • Paclitaxel
Trial Overview The study tests heated chemotherapy (HIPEC) with Cisplatin and Paclitaxel delivered directly into the abdomen during surgery to prevent cancer recurrence. It's a phase II trial focusing on whether this method can reduce the risk of peritoneal recurrence.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (p-HIPEC, cisplatin, paclitaxel)Experimental Treatment11 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Hyperthermic intraperitoneal chemotherapy (HIPEC) and ...Prophylactic intraperitoneal chemotherapy associated to neoadjuvant chemotherapy increases the DFS and OS in patients with AGC without peritoneal carcinosis.
Review Article Outcomes of intraperitoneal chemotherapy ...Median overall survival determined was 16.4 months (95%CI, 14.4–18.4). Meta-analysis of data from eight studies comparing combined intraperitoneal and systemic ...
Effect of Hyperthermic Intraperitoneal Chemotherapy on ...Retrospective observational studies revealed an increased median overall survival (OS) of up to 27.7 months after the combination of CRS and ...
Evaluation of the feasibility, safety, and preliminary ...The results indicate that patients in the HIPEC group had lower peritoneal recurrence rates compared to the surgery-alone group, suggesting that HIPEC may be ...
Overall and disease-free survival in patients treated with CRS ...Conclusions: HIPEC and CRS with cisplatin and paclitaxel in patients with PC from GC showed promising results in improving the DFS and the OS, particularly for ...
Overall and disease-free survival in patients treated with ...CRS + HIPEC with cisplatin and paclitaxel is a safe and effective treatment for GC with PC compared to traditional treatments, especially in patients with PCI < ...
Phase I trial of hyperthermic intraperitoneal ...One- and 2-year OS rates from the date of metastatic disease were 74% and 58%, respectively. The 1-year OS rate from the date of HIPEC was 51%.
Phase II trial of prophylactic hyperthermic intraperitoneal ...Prophylactic HIPEC with cisplatin was safe and well tolerated in patients with locally advanced gastric cancer. The survival benefit of HIPEC as ...
Intraperitoneal paclitaxel for gastric cancer with peritoneal ...Especially, the median survival times for the IP and SP arms were approximately 18 and 15 months, respectively, and the 3-year overall survival ...
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