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
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.
Eligibility criteria
This trial does not accept healthy volunteers
Qualifiers
Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.
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. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo/radioembolization (cholangiocarcinomas).
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 following resection based on future liver remnant or a combination of partial hepatectomy and microwave ablation or trans-arterial radioembolization (TARE).
Disqualifiers
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 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sequential cytoreductive intervention
Procedure/Surgery
A treatment plan that involves multiple procedures given one after another to remove cancerous tumors depending on metastasis.
Signatera Genome ultra-sensitive ctDNA blood test
Diagnostic test
A personalized blood test that detects circulating tumor DNA (ctDNA) to monitor for molecular residual disease (MRD) in patients who have been diagnosed with cancer.
Treatment groups
54 Participants
are divided into 2 treatment groups
Group A: Sequential cytoreductive interventionExperimental treatment 2 interventions
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Progression Free Survival (PFS)
PFS is defined as the time from randomization to first documented disease progression by Resist 1.1 criteria or death from any cause, whichever occurs first.
Time frame
up to 12 months post-randomization
Secondary outcomes
1
Post treatment survival rate
One year post treatment survival rate: Defined as the number of participants alive at one year after intervention.
Time frame
12 months post-randomization
2
Change in European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) Global Health Status score
EORTC QLQ-C30 is a questionnaire with a global health status/QoL scale that uses a 7-point scale scoring with anchors (1=very poor and 7=excellent). Score range: 0 to 100.Higher score: Indicates a better global health status and quality of life.
Time frame
Post randomization at weeks 1, 3, 5, 9 and at first followup (up to 3 months)
3
Change in European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) Physical Functioning score
EORTC QLQ-C30 is a questionnaire with a physical functioning scale. Score range: 0 to 100.Higher score: Indicates a better global health status and quality of life.
Time frame
Post randomization at weeks 1, 3, 5, 9 and at first followup (up to 3 months)
4
Change in Comprehensive Score for Financial Toxicity (COST) score
A lower COST score indicates higher financial toxicity, with the total score ranging from 0 to 44,
Time frame
Post randomization at weeks 1, 3, 5, 9 and at first followup (up to 3 months)
Other outcomes
Sponsors and contacts
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