Impact of Early FDG-PET Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study

Status: Terminated
Location: See all (71) locations...
Intervention Type: Drug, Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ Pre-Registration Eligibility Criteria

⁃ Documentation of Disease

• 1 Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II, III)

• 2 Pre-treatment clinical stage of T3-4N any M0 or T any N positive M0 as determined by laparoscopy, CT scan (or PET/CT), or endoscopic ultrasound (histologic confirmation of lymph involvement is not required). Therefore, patients can have measurable or non-measurable disease.

• 3 Patients with T1-2N0M0 tumors or patients with metastatic disease are NOT eligible.

⁃ Patients must be eligible for curative intent surgical resection.

⁃ FDG Avid malignancy - Patients must have an FDG avid tumor(s). FDG avid tumors are defined as a primary tumor with an increased uptake in the region of the tumor that has an SUV of > 5.0 or a tumor:liver SUV ratio of > 1.5.

⁃ No prior history of congestive heart failure - NYHA class I to IV or known DPD deficiency

⁃ No current grade 2, 3, or 4 of neuropathy.

⁃ No known hypersensitivity to epirubicin, oxaliplatin and cisplatin, capecitabine and 5-flurouracil, docetaxel or irinotecan.

⁃ Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects.

• 1 Therefore, for women of childbearing potential only, a negative serum pregnancy test pregnancy test done ≤ 7 days prior to pre-registration is required.

• 2 A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

⁃ Age ≥ 18 years

⁃ ECOG Performance Status 0 or 1

⁃ Required Initial Laboratory Values:

⁃ Absolute Neutrophil Count (ANC) ≥ 1,500/mm^3

⁃ Platelet Count ≥ 100,000/mm^3

⁃ Creatinine ≤ 1.5 x upper limit of normal (ULN)

⁃ Total Bilirubin ≤ 1.5 x ULN, except in patients with Gilbert's disease

⁃ AST and ALT ≤ 2.5 x ULN

⁃ Alkaline Phosphatase ≤ 2.5 x ULN

⁃ Registration Eligibility Criteria to Treatment Arms A or B

⁃ Patient must continue to be eligible for curative intent surgical resection.

⁃ Disease Progression: FDG avid malignancy that is classified as an FDG PET non- responder. PET non-responders are defined as having < 35% reduction in the FDG uptake of the primary tumor when compared to baseline.

⁃ Concomitant Medications -

• 1 Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this trial. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study treatment.

• 2 Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

⁃ Patient must have received only one cycle of the following regimens during the pre-registration time period and no other therapy for gastric or gastroesophageal junction cancer:

⁃ Epirubicin, Oxaliplatin, and Capecitabine

⁃ Epirubicin, Oxaliplatin, and Fluorouracil

⁃ Epirubicin, Cisplatin, and Capecitabine

⁃ Epirubicin, Cisplatin, and Fluorouracil

⁃ Toxicity recovery should include the following:

⁃ Grade ≤ 2 neuropathy

⁃ Grade ≤ 2 diarrhea

⁃ Grade ≤ 2 mucositis

⁃ Pre-registration chemotherapy given within 42 days of treatment (treatment meaning surgery if Arm A, chemotherapy if Arm B)

Locations
United States
California
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
Saint Helena Hospital
Saint Helena
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Helen F Graham Cancer Center
Newark
Medical Oncology Hematology Consultants PA
Newark
Regional Hematology and Oncology PA
Newark
Georgia
Emory University Hospital Midtown
Atlanta
Emory University/Winship Cancer Institute
Atlanta
Hawaii
Hawaii Oncology Inc-Pali Momi
'aiea
Hawaii Cancer Care Inc-Liliha
Honolulu
Hawaii Cancer Care Inc-POB II
Honolulu
Hawaii Oncology Inc-Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
Idaho
Kootenai Cancer Center
Post Falls
Illinois
John H Stroger Jr Hospital of Cook County
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
Northwestern Medicine Cancer Center Delnor
Geneva
Northwestern Medicine Cancer Center Warrenville
Warrenville
Indiana
Memorial Regional Cancer Center Day Road
Mishawaka
Reid Health
Richmond
Memorial Hospital of South Bend
South Bend
Massachusetts
Dana-Farber Cancer Institute
Boston
Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor
Minnesota
Fairview-Southdale Hospital
Edina
Abbott-Northwestern Hospital
Minneapolis
Missouri
Freeman Health System
Joplin
Delbert Day Cancer Institute at PCRMC
Rolla
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla
Mercy Hospital Saint Louis
Saint Louis
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Mississippi
University of Mississippi Medical Center
Jackson
Montana
Billings Clinic Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Kalispell Regional Medical Center
Kalispell
North Carolina
Wayne Memorial Hospital
Goldsboro
New Jersey
Memorial Sloan Kettering Basking Ridge
Basking Ridge
Englewood Hospital and Medical Center
Englewood
New Mexico
University of New Mexico Cancer Center
Albuquerque
New York
Memorial Sloan-Kettering Cancer Center
New York
Weill Medical College of Cornell University
New York
Ohio
Oncology Hematology Care Inc-Blue Ash
Cincinnati
Good Samaritan Hospital - Dayton
Dayton
Miami Valley Hospital
Dayton
Samaritan North Health Center
Dayton
Blanchard Valley Hospital
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Wayne Hospital
Greenville
Kettering Medical Center
Kettering
Springfield Regional Medical Center
Springfield
Upper Valley Medical Center
Troy
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
South Carolina
Medical University of South Carolina
Charleston
Greenville Health System Cancer Institute-Andrews
Greenville
Greenville Health System Cancer Institute-Butternut
Greenville
Greenville Health System Cancer Institute-Eastside
Greenville
Greenville Health System Cancer Institute-Faris
Greenville
Greenville Health System Cancer Institute-Greer
Greer
Greenville Health System Cancer Institute-Seneca
Seneca
Greenville Health System Cancer Institute-Spartanburg
Spartanburg
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond
Vermont
University of Vermont College of Medicine
Burlington
Time Frame
Start Date: August 2015
Completion Date: August 2018
Participants
Target number of participants: 5
Treatments
Active Comparator: Arm A - surgery, chemotherapy and radiation therapy
Patients undergo surgery within 42 days of completion of pre-registration chemotherapy. Beginning within 49 days of surgery, patients receive 5-FU IV continuously and capecitabine PO BID on days 1-7, and undergo 3D-CRT or IMRT QD on days 1-5. Treatment continues for 5 weeks in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B - surgery, chemotherapy and FDG-PET
Beginning within 28 days of day 1 of pre-registration chemotherapy, patients receive docetaxel IV and irinotecan IV on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. Beginning within 42 days of completion of docetaxel and irinotecan, patients undergo surgery. Patients also undergo FDG-PET within 14 days of planned surgery. Beginning within 60 days after surgery, patients receive 3 additional courses of docetaxel and irinotecan hydrochloride courses in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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