Sequential Cytoreductive Intervention for Upper Gastrointestinal Cancer
(OLIGOMETS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to compare a new treatment, sequential cytoreductive intervention, with the usual care for individuals with specific types of stage IV upper gastrointestinal cancer. It focuses on patients who have responded well to initial chemotherapy and have undetectable cancer DNA afterward. The trial seeks participants with a confirmed diagnosis of resectable or treatable esophageal, gastric, pancreatic, or other upper GI cancers, who have limited metastases that can potentially be removed or treated. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that a step-by-step approach to reducing tumor size is generally safe for patients. One study found the risk of dying within 30 days after the procedure was very low, at just 1.1%. Only a few patients faced serious health issues soon after the treatment.
This method has been used in other conditions, like cancer in the abdominal lining, with similarly safe results. This consistency suggests the procedure is safe.
While all medical treatments carry some risks, previous studies indicate this method is relatively safe for carefully selected patients. Patients should always discuss potential risks with their healthcare provider to determine if this trial is suitable for them.12345Why are researchers excited about this study treatment for upper gastrointestinal cancer?
Researchers are excited about the sequential cytoreductive intervention for upper gastrointestinal cancer because it offers a novel approach compared to the standard chemotherapy and radiation treatments. Unlike traditional methods that primarily aim to shrink tumors through chemical or radiation exposure, this intervention targets cancer by sequentially reducing tumor load after achieving undetectable levels of circulating tumor DNA (ctDNA). This approach could potentially lead to more precise and effective management of the disease, as it focuses on maintaining minimal residual disease, which is a promising strategy in preventing cancer progression. Additionally, the use of ctDNA as a biomarker to guide treatment decisions represents a cutting-edge tool that may enhance personalized care for patients.
What evidence suggests that sequential cytoreductive intervention could be an effective treatment for upper gastrointestinal cancer?
Research has shown that a step-by-step approach to reducing tumor size can extend the lives of patients with upper gastrointestinal cancers. In this trial, one group of participants will receive the standard of care therapy, while another group will undergo sequential cytoreductive interventions. One study found that combining surgery to remove the tumor with chemotherapy increased the average survival time to about 49.4 months, compared to 24.0 months for surgery alone. Other studies have indicated that some patients have a 31% chance of living for five years. These findings suggest that removing as much of the tumor as possible, followed by chemotherapy, may improve patient survival.16789
Who Is on the Research Team?
Kiran Turaga, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for patients with certain upper GI tract cancers (like esophageal, pancreatic, stomach) that have spread. They must have already had chemotherapy and show no cancer DNA in their blood. People who can't undergo further medical procedures or don't meet specific health conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants undergo a three-month induction chemotherapy period to determine ctDNA levels
Randomization and Treatment
Participants are randomized to either continue standard of care therapy or undergo sequential cytoreductive interventions
Follow-up
Participants are monitored for progression-free survival and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Sequential cytoreductive intervention
Trial Overview
The study compares standard cancer care to an added 'sequential cytoreductive intervention' after initial chemo in patients without detectable circulating tumor DNA. It's a phase 2 trial where participants are randomly chosen to receive either the standard treatment or the additional intervention.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Following the determination of undetectable levels of ctDNA, patients will undergo cytoreductive interventions for a total of three months. All sequential cytoreductive interventions must be completed within the three-month time frame following randomization. ctDNA levels will be measured.
Following the determination of undetectable levels of ctDNA, patients will continue the standard of care therapy until progression.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Citations
Survival outcomes after cytoreductive surgery and ...
The median survival for all patients ranged from 6.6 to 15.8 months. The 5-years overall survival ranged from 6 to 31%.
2.
clinicaltrials.gov
clinicaltrials.gov/study/NCT03023436?term=hipec&cond=stomach%20cancer&viewType=Table&rank=7Cytoreductive Surgery Combined With HIPEC and ...
In order to evaluate the survival benefit and safety of cytoreductive surgery(CRS) and HIPEC before beginning chemotherapy in gastric cancer with peritoneal ...
State-of-the-Art Advancements in Gastroesophageal ...
The median overall survival (OS) was 49.4 months in the neoadjuvant therapy group versus 24.0 months in the resection-alone group (hazard ratio ...
Advancing gastric cancer treatment
Therapeutically, HIPEC combined with cytoreductive surgery improves survival in selected patients with peritoneal metastases. Prophylactically, ...
Enhanced recovery after surgery protocols in gastrectomy ...
Three-year overall survival rates as high as 21.9% have been reported with IP[15]. Pressurized intraperitoneal aerosolized chemotherapy offers ...
Trial Comparing Standard of Care Therapy With and ...
The primary objective of this study is to assess the Progression Free Survival (PFS) of patients with the addition of sequential cytoreductive ...
Morbidity and Mortality Rates Following Cytoreductive ...
Overall 30-day mortality was lower in CRS/HIPEC (1.1%; 95% CI, 0.6%-1.6%) compared with Whipple (2.5%; 95% CI, 2.3%-2.7%), right lobe ...
Outcomes for cytoreductive surgery and hyperthermic ...
CRS-HIPEC procedures for peritoneal carcinomatosis in the elderly demonstrate comparable perioperative outcome in well-selected patients.
Developing a Core Outcome Set for Cytoreductive Surgery ...
Cytoreductive surgery (CRS) with or without intraperitoneal chemotherapy (IPC) provides a chance of survival for selective patients with ...
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