Spots Global Cancer Trial Database for FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer
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Trial Identification
Brief Title: FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer
Official Title: Impact of Early FDG-PET Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study
Study ID: NCT02485834
Study Description
Brief Summary: This randomized phase II trial studies how well fludeoxyglucose F-18 (FDG)/positron emission tomography (PET) directed treatment improves response in patients with stomach or gastroesophageal junction cancer that has not spread past the stomach and is not responding to the usual treatment. PET scans are a different way to take pictures of cancer and can be used to look at how much energy (such as glucose) is being used by the cancer. Using PET scans early to monitor the success of treatment may allow doctors to measure response and change treatment accordingly.
Detailed Description: Pre-registered patients receive standard pre-operative chemotherapy comprising epirubicin intravenously 50mg/m\^2 (IV) on day 1; oxaliplatin 130 mg/m\^2 IV or cisplatin 60 mg/m\^2 IV on day 1; and capecitabine 625 mg/m\^2 orally (PO) twice daily (BID) or fluorouracil 200 mg/m\^2/day IV continuously on days 1-21; and undergo FDG-PET following course 1 (days 15-19). Patients defined as FDG-PET non-responders are registered and randomized to 1 of 2 treatment arms. Primary objective To assess and compare the overall survival (OS) of patients with locally advanced gastric cancer classified as FDG-PET non-responders after one cycle of pre-operative chemotherapy randomly assigned to receive either salvage chemotherapy before and after surgery or immediate surgery followed by fluorouracil sensitized radiotherapy. Secondary objectives 1. To assess and compare progression-free survival (PFS) between the treatment arms (Arms A and B). 2. To assess and compare R0 resection rate between the treatment arms (Arms A and B). 3. To assess and compare pathologic complete response (pCR) rate between the treatment arms (Arms A and B). 4. To assess the adverse events (AE) profile and safety of each treatment arm (Arms A and B), including post-operative mortality rate, 30-day post-operative targeted adverse events (i.e., dehiscence, significant infection, and re-operation rate). 5. To examine the changes of FDG-PET SUV induced by pre-operative chemotherapy at different time points (from baseline to completion of one cycle of treatment before randomization, and 2 cycles of salvage treatment) in patients randomized to salvage treatment arm (Arm B). 6. To collect measurement of fatigue and overall perception of QOL at registration of the study (Alliance registration QOL assessment study).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Saint Helena Hospital, Saint Helena, California, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Regional Hematology and Oncology PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Hawaii Oncology Inc-Pali Momi, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc-POB II, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States
Hawaii Oncology Inc-Kuakini, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Memorial Regional Cancer Center Day Road, Mishawaka, Indiana, United States
Reid Health, Richmond, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Freeman Health System, Joplin, Missouri, United States
Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
Billings Clinic Cancer Center, Billings, Montana, United States
Saint Vincent Healthcare, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Weill Medical College of Cornell University, New York, New York, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Health Center, Dayton, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Springfield Regional Medical Center, Springfield, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Providence Saint Vincent Medical Center, Portland, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Greenville Health System Cancer Institute-Andrews, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer, Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca, Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
University of Vermont College of Medicine, Burlington, Vermont, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: Manish Shah, MD
Affiliation: Weill Medical College of Cornell University
Role: STUDY_CHAIR
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