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Adenocarcinoma of the Gastroesophageal JunctionPhase 2NCT02485834

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

A Phase 2 study testing FDG-PET, surgery and 5-FU in people with Adenocarcinoma of the Gastroesophageal Junction and Gastric Adenocarcinoma, run by Alliance for Clinical Trials in Oncology at 71 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FDG-PET, surgery and 5-FU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
71 sitesUnited States
Study dates
12 Nov 2015to 1 Aug 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  1. Toxicity recovery should include the following:
  • Grade ≤ 2 neuropathy
  • Grade ≤ 2 diarrhea
  • Grade ≤ 2 mucositis
  1. Pre-registration chemotherapy given within 42 days of treatment (treatment meaning surgery if Arm A, chemotherapy if Arm B)

Trial locations and contacts

71 sites in 1 country.

71 sites in 1 country

United States71 sites

  • Hawaii Oncology Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Oncology Inc-Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Freeman Health System

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46545

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Reid Health

    Richmond, Indiana, 47374

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Saint John's Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45505

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Saint Helena Hospital

    St. Helena, California, 94574

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

Other trials in United States

About this study

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

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.

Read the 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).
Being tested
FDG-PET, surgery, 5-FU, capecitabine, docetaxel
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDG-PETProcedure or surgery

  • surgeryProcedure or surgery

  • 5-FUDrug

    200 mg/m^2/day IV

  • capecitabineDrug

    oral 800 mg/m^2 BID

  • docetaxelDrug

    30 mg/m^2 IV

  • IrinotecanDrug

    50 mg/m^2 IV

  • 3D-CRTRadiation

  • IMRTRadiation

Study groups in NCT02485834
Study groupRoleWhat they receive
Arm A - surgery, chemotherapy and radiation therapyActive comparatorPatients 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.
Receives: Procedure: surgery; Drug: 5-FU; Drug: capecitabine; Radiation: 3D-CRT; Radiation: IMRT
Arm B - surgery, chemotherapy and FDG-PETExperimentalBeginning 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.
Receives: Procedure: FDG-PET; Procedure: surgery; Drug: docetaxel; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

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

    Measured: Up to 3 years

Secondary outcomes (4)

  1. Progression-free Survival

    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.

    Measured: Up to 3 years

  2. Number of Patients Achieved R0 Resection During Surgery

    The number of patients achieved R0 resection during surgery

    Measured: At time of surgery

  3. Number of Patients Had Pathologic Complete Response

    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.)

    Measured: Up to 3 years

  4. Number of Participants Who Reported Grade 3 or Higher Adverse Events

    The number of patients who reported grade 3 or higher Adverse Events according to Common Terminology Criteria for Adverse Events version 4.0.

    Measured: Up to 30 days after completion of protocol treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2015 (estimated)
  2. Study start12 Nov 2015
  3. Primary completion1 Aug 2018
  4. Study completion1 Aug 2018

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02485834
Sponsor's protocol ID
A021302
Other IDs
U10CA180821, NCI-2014-02566
Status last verified
Jan 2025
First submitted
25 Jun 2015
Last updated
20 Jan 2025
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FDG-PET, surgery and 5-FU in people with Adenocarcinoma of the Gastroesophageal Junction and Gastric Adenocarcinoma, run by Alliance for Clinical Trials in Oncology at 71 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02485834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.

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