Heated Chemotherapy for Gastric Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo gastrectomy with reconstruction and D2 lymphadenectomy, and receive p-HIPEC with cisplatin and paclitaxel intraperitoneal over 90 minutes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood sample collection and imaging
Long-term Follow-up
Participants are followed for recurrence-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Hyperthermic Intraperitoneal Chemotherapy
- Paclitaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor