Mass-Based Response Drug Screening for Appendiceal and Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to personalize chemotherapy for individuals with specific cancers, particularly high-grade appendiceal adenocarcinomas and colorectal cancer that have metastasized to the abdominal lining. The researchers focus on using mass-based response testing (MRT) to customize hyperthermic intraperitoneal chemotherapy (HIPEC), a heated chemotherapy treatment applied directly into the abdominal cavity, for each patient. Suitable candidates for this trial have a confirmed diagnosis of cancer confined to the abdomen, with limited or no spread beyond that area, and have not undergone extensive previous treatments like radiation or surgery.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in personalized cancer treatment.
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 coordinators or your doctor to get a clear answer.
What prior data suggests that mass-based response testing (MRT) is safe for selecting and delivering HIPEC regimens?
Research has shown that Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is generally well-tolerated. In studies involving patients with colorectal and appendiceal cancer, HIPEC has been linked to improved survival rates. For instance, one study found that patients with colorectal cancer who received HIPEC had a 3-year disease-free survival rate of 83.9%, compared to 67.2% for those who did not receive the treatment.
Another study demonstrated that patients with appendiceal cancer lived for a median of 64.4 months after undergoing repeat HIPEC procedures. While these studies focus on HIPEC's effectiveness, they also suggest it is fairly safe, as it is already used for these cancer types.
Side effects can occur, as with any treatment, but these studies suggest that HIPEC is relatively well-tolerated. Discussing any concerns with a healthcare provider is important to understand what this might mean for an individual's specific situation.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a personalized approach to treating high-grade appendiceal and colorectal peritoneal metastasis. Unlike standard chemotherapy treatments that take a one-size-fits-all approach, this method uses mass-based response drug screening to tailor Hyperthermic Intraperitoneal Chemotherapy (HIPEC) regimens to individual patients. This customization aims to increase effectiveness by selecting drugs that specifically target the tumor's unique characteristics. By potentially improving the precision of treatment, this approach could lead to better outcomes for patients with these challenging cancers.
What evidence suggests that mass-based response testing is effective for selecting personalized HIPEC regimens for appendiceal and colorectal cancer?
Research has shown that Hyperthermic Intraperitoneal Chemotherapy (HIPEC) can effectively treat cancer that has spread to the abdominal lining from certain appendix and colon cancers. In one study, patients who underwent surgery with HIPEC had a 58.39% chance of survival after four years, compared to 33.33% for those who only had surgery. Another study found that HIPEC helped control cancer spread in the abdominal area over three years. Additionally, HIPEC has reduced the recurrence of some types of colon cancer. Overall, these findings suggest that HIPEC may extend patient survival and reduce cancer recurrence. Participants in this trial will receive personalized HIPEC regimens selected through MRT to potentially enhance these benefits.46789
Who Is on the Research Team?
Kiran Turaga, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for patients with advanced appendiceal or colorectal cancer that has spread to the lining of the abdomen. Participants should have high-grade tumors and be candidates for a specific type of heated chemotherapy delivered directly into the abdomen.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
MRT and Initial Laparoscopy
Mass-based response testing (MRT) is performed on tissue biopsies to determine the optimal chemotherapy regimen. Initial laparoscopy is conducted to assess the extent of peritoneal metastasis.
Iterative HIPEC (IHIPEC)
Patients undergo iterative hyperthermic intraperitoneal chemotherapy (IHIPEC) starting three weeks after the laparoscopy. This involves HIPEC followed by systemic chemotherapy, repeated 3 times with approximately 6 weeks in between each HIPEC.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and financial toxicity.
What Are the Treatments Tested in This Trial?
Interventions
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Trial Overview
The study is testing mass-based response testing (MRT) to personalize hyperthermic intraperitoneal chemotherapy (HIPEC). It aims to determine if MRT can help tailor HIPEC treatment more effectively for each patient's unique cancer profile.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with high-grade appendiceal and colorectal peritoneal metastasis will receive MRT to select and deliver personalized HIPEC regimens to participants undergoing IHIPEC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Travera Inc
Industry Sponsor
Citations
Outcome of Cytoreductive Surgery and Hyperthermic ...
Four-year actuarial survival was 58.39% for subjects undergoing CRS and HIPEC and 33.33% for those who received CRS alone. From the findings it was concluded ...
5-Year Results of a Randomized Multicenter Trial
Five-year peritoneal metastases-free survival rates were 63.9% and 63.2% (P = .907) and 5-year disease-free survival was 55.7% and 52.3% (log- ...
Oncological Outcomes From Cytoreductive Surgery and ...
This study evaluates outcomes for CRPM patients undergoing CRS+HIPEC with Oxaliplatin (Ox) 368mg/m 2 (30 min), versus Mitomycin C (MMC) 35mg/m 2 (90min).
Adjuvant hyperthermic intraperitoneal chemotherapy in ...
Adjuvant HIPEC significantly reduced the locoregional recurrence rate in right-sided locally advanced colon cancer, but not in the overall study population.
Efficacy and Safety of Intraoperative Hyperthermic ...
Findings This phase 3 randomized clinical trial of 184 adults in Spain showed an improvement in the locoregional control rate at 3 years in the ...
Short and long-term outcomes of cytoreductive surgery with ...
Short and long-term outcomes of cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for colorectal and appendiceal cancer ...
Outcomes for cytoreductive surgery and hyperthermic ...
Median survival for the colorectal/appendiceal carcinomatosis patients in Group 1 (n = 81) was 29.79 (SE 4.7) months and in Group 2 (n = 20) was 21.2 (SE 3.0) ...
Prophylactic hyperthermic intraperitoneal chemotherapy in ...
Results: Before PSM, of 220 CRC patients enrolled, the 3-year DFS was 83.9% in the HIPEC group, which was better than 67.2% in the control group ...
Evaluation of repeat cytoreductive surgery and heated ...
For patients with appendiceal cancer, median disease-free survival was 15 months and overall survival was 64.4 months. Conclusion. Repeat CRS/HIPEC procedures ...
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