BridgeMD
New treatment option for Appendiceal Cancer
Official title 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
ClinicalTrials.gov ID: NCT07291180
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 81
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- 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...
- Has known significant extraperitoneal metastasis.
- Has creatine clearance \<60 mL/m\^2 per the Cockcroft-Gault formula
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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)...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 81 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.