A Feasibility Study of Mass-Based Response Drug Screening to Guide Personalized Hyperthermic Intraperitoneal Chemotherapy for High-Grade Appendiceal and Colorectal Adenocarcinoma With Peritoneal Metastasis
This study will evaluate the role of mass-based response testing (MRT) to select and deliver personalized hyperthermic intraperitoneal chemotherapy (HIPEC) regimens to patients with peritoneal metastasis (PM) from high-grade appendiceal adenocarcinomas (HGAA) and colorectal cancer (CRC).
• Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV
‣ Appendiceal adenocarcinoma (moderately/poorly differentiated, and/or signet ring cell tumors)
⁃ Colorectal adenocarcinoma
⁃ Suspected colon, small bowel, or appendiceal adenocarcinoma in setting of unknown primary
• Limited or no extraperitoneal metastases (any of the below)
• a) Any extraperitoneal metastases must be limited, stable and treatable
• Has adequate organ function, as described below; all screening laboratory tests should be performed within 30 days prior to the first HIPEC
• Expected survival at the time of first HIPEC is greater than 3 months
• Exhibits unresectable disease (bowel or mesenteric involvement) or PCI \> 19
∙ Demographics
• Adult patient at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.
• Has an ECOG performance status score of 0-2.
∙ Male Participants
• A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.
∙ Female Participants
• A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence). Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.
∙ Informed Consent
• The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for FBR. However, the participant may participate in the main study without participating in FBR.
∙ Alternative Eligibility
• In addition to the criteria above, if a patient has undergone less than 8 rounds of chemotherapy at another institution (prior to initial diagnostic laparoscopy) and has not undergone radiation, ablative procedures, or cytoreductive surgery, then they are still eligible to enter the study at the second diagnostic laparoscopy step