FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Alliance for Clinical Trials in Oncology
- Study ID
- NCT02485834
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Adenocarcinoma of the Gastroesophageal Junction
- Gastric Adenocarcinoma
- Gastric Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- FDG-PET — PROCEDURE
- surgery — PROCEDURE
- 5-FU — DRUG200 mg/m\^2/day IV
- capecitabine — DRUGoral 800 mg/m\^2 BID
- docetaxel — DRUG30 mg/m\^2 IV
- Irinotecan — DRUG50 mg/m\^2 IV
- 3D-CRT — RADIATION
- IMRT — RADIATION
Study Details
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.
Key Dates
- Start date
- Nov 12, 2015
- Status verified
- Jan 2025
- Primary completion
- Aug 1, 2018
- Completion
- Aug 1, 2018
Study Design
- Enrollment
- 5 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm A - surgery, chemotherapy and radiation therapyPatients 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-PETBeginning 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.
Primary Outcome Measure
Overall Survival [ Time Frame: Up to 3 years ]
Locations (71)
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Los Angeles County-USC Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CASaint Helena Hospital· St. Helena, CAChristiana Care Health System-Christiana Hospital· Newark, DEHelen F Graham Cancer Center· Newark, DEMedical Oncology Hematology Consultants PA· Newark, DE
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