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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 81 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "In this study, patients with unresectable colorectal and appendiceal peritoneal metastases will undergo MRT on tissue biopsies to determine optimal chemotherapy regimen to be delivered intraperitoneally."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether mass-based response testing (MRT), a drug response test, can help choose a person's chemotherapy. It is for adults with certain advanced appendix or colorectal cancers that have spread to the lining inside the belly. The treatment uses heated chemotherapy inside the belly, called HIPEC.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 to 80 and able to do self-care and be out of bed for at least half the day.
- Have stage IV cancer spread to the belly lining, confirmed by a tissue test. Eligible cancers include certain appendix cancers, colorectal cancer, or suspected colon, small bowel, or appendix cancer when the starting site is unknown.
- Have no cancer outside the belly lining, or only limited spread that is stable and treatable.
- Have cancer that cannot be removed by surgery because it involves the bowel or nearby supporting tissue, or a cancer-spread score called PCI above 19.
- Have organs working well enough, with lab tests within 30 days before the first HIPEC, and be expected to live more than 3 months.
- Men must use birth control or avoid sex during treatment and for at least 95 days afterward, and not donate sperm during that time. Women who can become pregnant must not be pregnant or breastfeeding and must use birth control or avoid sex.
- You or your legal representative must give written consent to join.
- Some people treated elsewhere may enter at the second belly-exam surgery if they had fewer than 8 chemotherapy rounds before the first exam and no radiation, tumor-destroying procedures, or surgery to remove cancer.
Who can't join
- Be pregnant, have an allergy to study drugs, or be unable to receive the chosen chemotherapy for medical or insurance reasons.
- Have major cancer spread outside the belly lining, or another cancer that could interfere with the study. Some treated skin cancers and cancers limited to their starting layer are allowed.
- Have low blood oxygen (below 92% at rest), need extra oxygen, have low kidney function, or have moderate to severe liver problems.
- Have serious heart disease, a heart attack within 6 months, or poorly controlled blood pressure of 150/90 or higher. An irregular heartbeat controlled with medicine is allowed.
- Have a mental health or substance use condition that prevents following study rules, trouble swallowing pills, or bowel problems that prevent absorbing medicine.
- Have cancer that worsens after the first 3 months of whole-body chemotherapy and be too unstable to continue; need emergency surgery for bleeding, a hole in the bowel, or a blockage; or have had repeated chemotherapy inside the belly before.
- Have had radiation, tumor-destroying procedures, surgery to remove cancer, or whole-body cancer treatment within 3 months of the first belly-exam surgery. The study lists a separate entry option for some people treated elsewhere.
- Have an active infection needing whole-body treatment, active TB or COVID, poorly controlled HIV or hepatitis B or C, a weak immune system, or recent immune-suppressing treatment, including long-term steroids above the study's dose limit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV 1. Appendiceal adenocarcinoma (moderately/poorly differentiated, and/or signet ring cell tumors) 2. Colorectal adenocarcinoma 3. 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 Exclusion Criteria: * Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Has a known allergy to medications used in this study. Note: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication. * Has hypoxia as defined by pulse oximeter reading \<92% at rest or requires intermittent or chronic supplemental oxygen. * No concurrent malignancy that may interfere with the study aims at the discretion of the investigator. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. * Has known significant extraperitoneal metastasis. * Has creatine clearance \<60 mL/m\^2 per the Cockcroft-Gault formula * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted. * Has poorly controlled hypertension defined as SBP ≥150mmHg and/or DBP ≥90mmHg. * Has moderate to severe hepatic impairment (Child-Pugh B or C). * Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study. * Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption). * Has progressive disease following the first 3 months of systemic chemotherapy prior to HIPEC who is not in a stable condition to continue with the trial. Prior/Concomitant Therapy * Has received radiation, ablative procedures, cytoreductive surgery, or systemic therapy including chemotherapy to treat metastatic disease within 3 months of initial laparoscopy. Diagnostic Assessments * Has an active infection requiring systemic therapy. * Has a known active TB/ COVID infection. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention. * Has a known history of poorly controlled HIV infection despite anti-retroviral therapy. * Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \[qualitative\] is detected) infection that is poorly controlled. Note: Testing for HBV and HCV is only required if mandated by the local health authority. Other Exclusions * Inability to receive chemotherapy due to medical/insurance reasons. * Requires emergency surgery due to bleeding, perforation, or obstruction. * Has undergone previous iterative intraperitoneal therapy. * Has contraindication to chemotherapy of choice.
Study sites (1)
CT
- Yale New Haven Hospital · New Haven, CT 06510More trials in New Haven