FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02485834|
Recruitment Status : Terminated (Poor accrual)
First Posted : June 30, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Gastroesophageal Junction Gastric Adenocarcinoma Gastric Cancer||Procedure: FDG-PET Procedure: surgery Drug: 5-FU Drug: capecitabine Drug: docetaxel Drug: Irinotecan Radiation: 3D-CRT Radiation: IMRT||Phase 2|
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.
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.
- To assess and compare progression-free survival (PFS) between the treatment arms (Arms A and B).
- To assess and compare R0 resection rate between the treatment arms (Arms A and B).
- To assess and compare pathologic complete response (pCR) rate between the treatment arms (Arms A and B).
- 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).
- 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).
- To collect measurement of fatigue and overall perception of QOL at registration of the study (Alliance registration QOL assessment study).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Early FDG-PET Directed Intervention on Preoperative Therapy for Locally Advanced Gastric Cancer: A Random Assignment Phase II Study|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
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.
200 mg/m^2/day IV
oral 800 mg/m^2 BID
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.
30 mg/m^2 IV
50 mg/m^2 IV
- Overall Survival [ Time Frame: Up to 3 years ]Overall survival is defined as the time from date of randomization to death due to any cause.
- Progression-free Survival [ Time Frame: Up to 3 years ]Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
- Number of Patients Achieved R0 Resection During Surgery [ Time Frame: At time of surgery ]The number of patients achieved R0 resection during surgery
- Number of Patients Had Pathologic Complete Response [ Time Frame: Up to 3 years ]The number of patients had pathologic complete response (pCR). (pCR is defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.)
- Number of Participants Who Reported Grade 3 or Higher Adverse Events [ Time Frame: Up to 30 days after completion of protocol treatment ]The number of patients who reported grade 3 or higher Adverse Events according to Common Terminology Criteria for Adverse Events version 4.0.
- Change in FDG-PET SUV Measures [ Time Frame: Up to 14 days prior to surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485834
|Study Chair:||Manish Shah, MD||Weill Medical College of Cornell University|