Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for … (NCT04931420) | Clinical Trial Compass
WithdrawnPhase 2
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
Stopped: PI left site
0Started 2022-05-19
Plain-language summary
This study is designed for participants who have cancer of the upper gastrointestinal (GI) tract such as cancer of the esophagus, stomach, duodenum (the initial portion of your small intestine), pancreas, bile duct (Cholangiocarcinoma), ampulla, or gall bladder with limited sites of spread (metastases). Doctors leading this study are looking to see if treating the disease using sequential procedures (more than one procedure given one after another) such as surgeries or radiation can lead to better survival and if these surgeries, combined with standard of care treatment, are safe for the treatment of upper GI cancers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has a newly diagnosed primary diagnosis of American Joint Committee of Cancer (AJCC) 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic/ampullary adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.
. All participants must have confirmed histologic diagnosis of the primary tumor
Exclusion criteria
. Has a primary tumor that must be locally resectable or can be treated definitively (see preferred intervention sequence). 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial has been listed as 'withdrawn' — can you help me understand what that means for my situation, and whether a similar study comparing chemotherapy with or without surgery is available somewhere else I could consider?
2Since this was a Phase 2 trial, it was still in a relatively early stage of testing — what does that tell us about how much was actually known about the safety and benefit of adding cytoreductive surgery after chemotherapy for metastatic foregut cancers like mine?
3The trial specifically focused on patients with 'undetectable circulating tumor DNA' — can you explain what that biomarker means, whether my cancer has been tested for it, and how it might affect which treatment path makes sense for me?
4Given that this study was comparing standard chemotherapy alone versus chemotherapy followed by surgery, is that surgical approach something that could still be considered for me outside of a clinical trial, and what would the risks look like?
5Since this trial is no longer enrolling, are there other active studies or treatment combinations you'd recommend I look into that are designed for metastatic gastric, gallbladder, or other foregut cancers?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see treatment algorithm) at the time of diagnosis (before induction chemotherapy). This includes:
. Up to 5 pulmonary metastasis amenable to wedge resection (maximum of 3 wedge resections) or lobectomy (single lobectomy) or consolidative radiation/ablative therapy
. Up to 5 hepatic metastasis amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy (not more than 3 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).
. Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites).
. 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 5 lesions will be considered oligometastatic.