FDG-PET Directed Treatment in Improving Response in Patients With Locally Advanced Stomach or Gastroesophageal Junction Cancer

Phase 2

Terminated

• Conditions: Adenocarcinoma of the Gastroesophageal Junction; Gastric Adenocarcinoma; Gastric Cancer
• Interventions: Procedure: surgery; Procedure: FDG-PET; Drug: 5-FU; Drug: docetaxel; Drug: capecitabine; Radiation: 3D-CRT; Drug: Irinotecan; Radiation: IMRT

• Registration Number: NCT02485834
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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).

Study Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Study Start: 2015-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Results First Submitted: 2019-08-07
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-10
• Last Update Submitted: 2019-09-10
• Results First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B - surgery, chemotherapy and FDG-PET	docetaxel	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.
Arm A - surgery, chemotherapy and radiation therapy	surgery	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.
Arm B - surgery, chemotherapy and FDG-PET	surgery	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.
Arm A - surgery, chemotherapy and radiation therapy	3D-CRT	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.
Arm A - surgery, chemotherapy and radiation therapy	IMRT	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.
Arm B - surgery, chemotherapy and FDG-PET	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.
Arm A - surgery, chemotherapy and radiation therapy	5-FU	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.
Arm A - surgery, chemotherapy and radiation therapy	capecitabine	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.
Arm B - surgery, chemotherapy and FDG-PET	Irinotecan	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival	Up to 3 years	Overall survival is defined as the time from date of randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	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	At time of surgery	The number of patients achieved R0 resection during surgery
Number of Patients Had Pathologic Complete Response	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	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.

Trial Locations

Locations (71)

Regional Hematology and Oncology PA; 🇺🇸 Newark, Delaware, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, 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-Seneca; 🇺🇸 Seneca, South Carolina, United States

Huntsman Cancer Institute/University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Kootenai Cancer Center; 🇺🇸 Post Falls, Idaho, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Memorial Hospital of South Bend; 🇺🇸 South Bend, Indiana, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Mercy Hospital Springfield; 🇺🇸 Springfield, Missouri, United States

Saint James Community Hospital and Cancer Treatment Center; 🇺🇸 Butte, Montana, United States

Greenville Health System Cancer Institute-Spartanburg; 🇺🇸 Spartanburg, South Carolina, United States

John H Stroger Jr Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States

Reid Health; 🇺🇸 Richmond, Indiana, United States

Memorial Regional Cancer Center Day Road; 🇺🇸 Mishawaka, Indiana, United States

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Emory University/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Freeman Health System; 🇺🇸 Joplin, Missouri, United States

Christiana Care Health System-Christiana Hospital; 🇺🇸 Newark, Delaware, United States

Saint Helena Hospital; 🇺🇸 Saint Helena, California, United States

Northwestern Medicine Cancer Center Warrenville; 🇺🇸 Warrenville, Illinois, United States

Medical Oncology Hematology Consultants PA; 🇺🇸 Newark, Delaware, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Northwestern Medicine Cancer Center Delnor; 🇺🇸 Geneva, Illinois, United States

Helen F Graham Cancer Center; 🇺🇸 Newark, Delaware, United States

Wayne Hospital; 🇺🇸 Greenville, Ohio, United States

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States

Greenville Health System Cancer Institute-Eastside; 🇺🇸 Greenville, South Carolina, United States

Kettering Medical Center; 🇺🇸 Kettering, Ohio, 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-Greer; 🇺🇸 Greer, South Carolina, United States

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States

Hawaii Oncology Inc-Pali Momi; 🇺🇸 'Aiea, Hawaii, United States

Straub Clinic and Hospital; 🇺🇸 Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha; 🇺🇸 Honolulu, Hawaii, United States

Fairview-Southdale Hospital; 🇺🇸 Edina, Minnesota, United States

Queen's Medical Center; 🇺🇸 Honolulu, Hawaii, United States

Hawaii Cancer Care Inc-POB II; 🇺🇸 Honolulu, Hawaii, United States

Hawaii Cancer Care Inc-Liliha; 🇺🇸 Honolulu, Hawaii, United States

Hawaii Oncology Inc-Kuakini; 🇺🇸 Honolulu, Hawaii, United States

Springfield Regional Medical Center; 🇺🇸 Springfield, Ohio, United States

Upper Valley Medical Center; 🇺🇸 Troy, Ohio, United States

Los Angeles County-USC Medical Center; 🇺🇸 Los Angeles, California, United States

Abbott-Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, 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

CoxHealth South Hospital; 🇺🇸 Springfield, Missouri, United States

Saint Vincent Healthcare; 🇺🇸 Billings, Montana, United States

Billings Clinic Cancer Center; 🇺🇸 Billings, Montana, United States

Bozeman Deaconess Hospital; 🇺🇸 Bozeman, Montana, United States

Benefis Healthcare- Sletten Cancer Institute; 🇺🇸 Great Falls, Montana, United States

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Kalispell Regional Medical Center; 🇺🇸 Kalispell, Montana, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

University of New Mexico Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

Wayne Memorial Hospital; 🇺🇸 Goldsboro, North Carolina, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, 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

Atrium Medical Center-Middletown Regional Hospital; 🇺🇸 Franklin, Ohio, United States

Blanchard Valley Hospital; 🇺🇸 Findlay, Ohio, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Samaritan North Health Center; 🇺🇸 Dayton, Ohio, United States

Greenville Health System Cancer Institute-Faris; 🇺🇸 Greenville, South Carolina, United States