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Compares treatment options for Foregut Adenocarcinoma
Official title Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels
ClinicalTrials.gov ID: NCT07282912
What this study is testing
- What it's testing
- This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 80
You may be able to join if
- Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic...
- Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal...
- Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of...
- Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative...
- Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments)...
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 hypoxia as defined by pulse oximeter reading \<92% at rest or requires intermittent or chronic supplemental oxygen.
- Has developed progressive disease on current line of systemic therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past three years. Note: Participants with basal...
- Has known CNS metastasis and/or carcinomatous meningitis.
- Has known osseous metastasis.
See the full eligibility criteria
Who can join
- Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma...
- Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma...
- Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:
- Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative radiation/ablative therapy
- Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments), wedge resection requiring a minimum of 40% of liver parenchyma...
- Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites) (see Appendix 3).
- Resectable peritoneal disease with a PCI of ≤6 and the ability to obtain a CC0 cytoreduction.
- Distant metastasis must be limited to two of the above-mentioned sites (a-d).
- If both pulmonary and liver metastasis are present (a, b), then a total of five lesions will be considered oligometastatic.
- Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.
- Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.
- Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.
- Patients must have at least 4 months of prior effective systemic therapy.
- Has hemoglobin ≥ 8 g/dL.
- Has ANC ≥ 1500/uL.
- Has platelet count ≥ 75000/uL.
- Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- Has aspartate aminotransferase (AST) \& alanine aminotransferase (ALT) ≤ 5 times ULN.
- Has creatinine clearance ≥ 50 mL/min.
- Patient who is 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 0-1 (see Appendix 6) at the time of randomization.
- 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) during the treatment period...
- The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the...
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. Note: In the event that 3...
- Has hypoxia as defined by pulse oximeter reading \<92% at rest or requires intermittent or chronic supplemental oxygen.
- Has developed progressive disease on current line of systemic therapy.
- Has a known additional malignancy that is progressing or has required active treatment within the past three years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or...
- Has known CNS metastasis and/or carcinomatous meningitis.
- Has known osseous metastasis.
- 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 known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.
- Has histologic subtypes not included in the inclusion criteria (including esophageal squamous cell carcinoma, gastroenteropancreatic neuroendocrine tumors, hepatocellular carcinoma, etc.).
- Has a primary tumor that is not amenable to the treatment modalities listed in section 3.
- Has albumin level less than 3.0 g/dL despite appropriate nutritional support. Diagnostic Assessments
- Has detectable ctDNA at the time of enrollment.
- Has an active infection requiring systemic therapy.
- Has 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...
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.
- Inability to receive chemotherapy and/or surgery and/or radiotherapy and/or ablative procedures due to medical/insurance reasons.
- Requires emergency surgery due to bleeding, perforation, or obstruction.
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 80 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.