Gastric Adenocarcinoma Clinical Trial
Official title:
Total Neoadjuvant Therapy for the Treatment of Gastroesophageal Junction (GEJ) and Gastric Cancers: A Pilot Trial
This phase I trial tests the safety, side effects studies chemotherapy followed by chemotherapy at the same time as radiation therapy (chemoradiation) before surgery (neoadjuvant) in treating patients with stage gastric (stomach) or gastroesophageal junction cancer . Chemotherapy drugs, such as docetaxel, oxaliplatin , leucovorin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy and chemoradiation before surgery may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with histologically proven, cT2N0-T4aN3M0 (TNM 8th edition), gastric or Siewert II-III GEJ adenocarcinoma - Evaluation with endoscopic ultrasound (EUS) and staging laparoscopy prior to enrollment is strongly recommended. - Patient should be a candidate for neoadjuvant chemotherapy with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) or fluorouracil and oxaliplatin (FOLFOX). - Patients should be >= 18 years old - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Patient should be eligible for surgical intervention - T1 N0 disease (assessed by endoscopic ultrasound) Exclusion Criteria: - Evidence of distant metastatic disease - Solitary functioning kidney within the potential radiation field - Peripheral polyneuropathy > National Cancer Institute (NCI) grade II |
Country | Name | City | State |
---|---|---|---|
United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Standard uptake value SUVmax metrics | Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection. | Up to 24 months | |
Other | Standard uptake value SUVpeak Tumor-to-liver metrics | Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection. | Up to 24 months | |
Other | Standard uptake value metabolic tumor volume metrics | Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection. | Up to 24 months | |
Other | Standard uptake value SUVmax Tumor-to-liver metrics | Will explore 18F-fluorodeoxyglucose (FDG) digital photon counting positron emission tomography (dPET) SUV metrics (e.g., SUVmax, SUVpeak, SUVmax Tumor-to-Liver, SUVpeak Tumor-to-Liver, metabolic tumor volume, etc.) on early dynamic PET perfusion, early tumor FDG uptake and delayed tumor FDG uptake to better predict pathologic response of primary tumor following multimodality therapy and surgical resection. | Up to 24 months | |
Primary | Number of patients able to complete all planned procedures and interventions successfully | Up to 24 months | ||
Primary | Incidence of adverse events | Up to within 30 days of discontinuation of protocol treatment | ||
Secondary | Resident microbiota species associated with higher response | Up to 24 months | ||
Secondary | Time to progression | From date of treatment completion to the event of interest or otherwise censored at last follow-up, assessed up to 12 months | ||
Secondary | Progression-free survival (PFS) | Kaplan-Meier analysis will be used to estimate PFS. PFS will include any failure (local, regional, or distant) or death from any cause. | From date of treatment completion to the event of interest or otherwise censored at last follow-up, assessed up to 12 months | |
Secondary | Overall survival (OS) | Kaplan-Meier analysis will be used to estimate OS. OS will be death from any cause. | From date of treatment completion to the event of interest or otherwise censored at last follow-up, assessed up to 12 months | |
Secondary | Perfusion and early tumor uptake kinetics of primary tumor using 8F-FDG dPET/CT approaches | To describe the perfusion and early tumor uptake kinetics of primary tumor targets at baseline, during and following systemic chemotherapy and chemoradiation therapies using 18F-FDG dPET/CT approaches | Up to 25 months | |
Secondary | 18F-FDG dPET/CT to evaluate and characterize residual primary tumor following neoadjuvant chemotherapy and initial chemoradiation therapy for subsequent adaptive boost radiation delivery. | Up to 12 months |
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