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

NCT02485834 | Terminated Phase 2 Results DMC

• 3 other identifiers: A021302U10CA180821NCI-2014-02566
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 71

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.

Conditions

Adenocarcinoma of the Gastroesophageal Junction; Gastric Adenocarcinoma; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival is defined as the time from date of randomization to death due to any cause.

  Up to 3 years

Secondary Outcomes (4)

• Progression-free Survival

  Up to 3 years

• Number of Patients Achieved R0 Resection During Surgery

  At time of surgery

• Number of Patients Had Pathologic Complete Response

  Up to 3 years

• Number of Participants Who Reported Grade 3 or Higher Adverse Events

  Up to 30 days after completion of protocol treatment

Other Outcomes (1)

• Change in FDG-PET SUV Measures

  Up to 14 days prior to surgery

Study Arms (2)

Arm A - surgery, chemotherapy and radiation therapy

ACTIVE COMPARATOR

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.

Procedure: surgery; Drug: 5-FU; Drug: capecitabine; Radiation: 3D-CRT; Radiation: IMRT

Arm B - surgery, chemotherapy and FDG-PET

EXPERIMENTAL

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.

Procedure: FDG-PET; Procedure: surgery; Drug: docetaxel; Drug: Irinotecan

Interventions

FDG-PET PROCEDURE

Arm B - surgery, chemotherapy and FDG-PET

surgery PROCEDURE

Arm A - surgery, chemotherapy and radiation therapy; Arm B - surgery, chemotherapy and FDG-PET

5-FU DRUG

200 mg/m\^2/day IV

Arm A - surgery, chemotherapy and radiation therapy

capecitabine DRUG

oral 800 mg/m\^2 BID

Arm A - surgery, chemotherapy and radiation therapy

docetaxel DRUG

30 mg/m\^2 IV

Arm B - surgery, chemotherapy and FDG-PET

Irinotecan DRUG

50 mg/m\^2 IV

Arm B - surgery, chemotherapy and FDG-PET

3D-CRT RADIATION

Arm A - surgery, chemotherapy and radiation therapy

IMRT RADIATION

Arm A - surgery, chemotherapy and radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Pre-Registration Eligibility Criteria 1. Documentation of Disease 1.1 Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II, III) 1.2 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. 1.3 Patients with T1-2N0M0 tumors or patients with metastatic disease are NOT eligible. 2. Patients must be eligible for curative intent surgical resection. 3. 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. 4. No prior history of congestive heart failure - NYHA class I to IV or known DPD deficiency 5. No current grade 2, 3, or 4 of neuropathy. 6. No known hypersensitivity to epirubicin, oxaliplatin and cisplatin, capecitabine and 5-flurouracil, docetaxel or irinotecan. 7. Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. 7.1 Therefore, for women of childbearing potential only, a negative serum pregnancy test pregnancy test done ≤ 7 days prior to pre-registration is required. 7.2 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). 8. Age ≥ 18 years 9. ECOG Performance Status 0 or 1 10. 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 1. Patient must continue to be eligible for curative intent surgical resection. 2. 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. 3. Concomitant Medications - 3.1 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. 3.2 Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment. 4. 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 5. Toxicity recovery should include the following: * Grade ≤ 2 neuropathy * Grade ≤ 2 diarrhea * Grade ≤ 2 mucositis 6. Pre-registration chemotherapy given within 42 days of treatment (treatment meaning surgery if Arm A, chemotherapy if Arm B)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (71)

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Saint Helena Hospital

St. Helena, California, 94574, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Regional Hematology and Oncology PA

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Hawaii Cancer Care Inc-POB II

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, 96817, United States

Location

Hawaii Oncology Inc-Kuakini

Honolulu, Hawaii, 96817, United States

Location

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States

Location

Hawaii Oncology Inc-Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

Location

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States

Location

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

Location

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, 46545, United States

Location

Reid Health

Richmond, Indiana, 47374, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Fairview-Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Freeman Health System

Joplin, Missouri, 64804, United States

Location

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401, United States

Location

Saint John's Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401, United States

Location

Mercy Hospital Springfield

Springfield, Missouri, 65804, United States

Location

CoxHealth South Hospital

Springfield, Missouri, 65807, United States

Location

Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59101, United States

Location

Saint Vincent Healthcare

Billings, Montana, 59101, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States

Location

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87102, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Oncology Hematology Care Inc-Blue Ash

Cincinnati, Ohio, 45242, United States

Location

Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Health Center

Dayton, Ohio, 45415, United States

Location

Blanchard Valley Hospital

Findlay, Ohio, 45840, United States

Location

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066, United States

Location

Wayne Hospital

Greenville, Ohio, 45331, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Springfield Regional Medical Center

Springfield, Ohio, 45505, United States

Location

Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, 29605, United States

Location

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, 29615, United States

Location

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, 29650, United States

Location

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, 29672, United States

Location

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, 29307, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Surgical Procedures, Operative; Fluorouracil; Capecitabine; Docetaxel; Irinotecan; Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Manish A. Shah MD
• Organization: Weill Medical College of Cornell University

mas9313@med.cornell.edu

646-962-6200

Study Officials

• Manish Shah, MD

  Weill Medical College of Cornell University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: June 30, 2015
• Study Start: November 12, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 20, 2025
• Results First Posted: September 11, 2019

Record last verified: 2025-01

Locations

US (71)