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FDG-PET Directed Treatment in...

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

Last Updated: 2025-01-20

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-12

Study Completion Date

2018-08-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Adenocarcinoma of the Gastroesophageal Junction Gastric Adenocarcinoma Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

5-FU

Intervention Type DRUG

200 mg/m\^2/day IV

capecitabine

Intervention Type DRUG

oral 800 mg/m\^2 BID

3D-CRT

Intervention Type RADIATION

IMRT

Intervention Type RADIATION

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.

Group Type EXPERIMENTAL

FDG-PET

Intervention Type PROCEDURE

surgery

Intervention Type PROCEDURE

docetaxel

Intervention Type DRUG

30 mg/m\^2 IV

Irinotecan

Intervention Type DRUG

50 mg/m\^2 IV

Interventions

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FDG-PET

Intervention Type PROCEDURE

surgery

Intervention Type PROCEDURE

5-FU

200 mg/m\^2/day IV

Intervention Type DRUG

capecitabine

oral 800 mg/m\^2 BID

Intervention Type DRUG

docetaxel

30 mg/m\^2 IV

Intervention Type DRUG

Irinotecan

50 mg/m\^2 IV

Intervention Type DRUG

3D-CRT

Intervention Type RADIATION

IMRT

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manish Shah, MD

Role: STUDY_CHAIR

Weill Medical College of Cornell University

Locations

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Los Angeles County-USC Medical Center

Los Angeles, California, United States

Site Status

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Saint Helena Hospital

St. Helena, California, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Regional Hematology and Oncology PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status