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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02485834
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 5
• Locations: 71
• Arms: 2
• Actual Duration (Months): 36
• Patients Per Site: 0.1
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Aug 1, 2015
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: surgery; Drug: 5-FU; 200 mg/m^2/day IV; Drug: capecitabine; oral 800 mg/m^2 BID; Radiation: 3D-CRT; Radiation: IMRT
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.	Procedure: FDG-PET; Procedure: surgery; Drug: docetaxel; 30 mg/m^2 IV; Drug: Irinotecan; 50 mg/m^2 IV

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Number of Patients Achieved R0 Resection During Surgery [At time of surgery]

   The number of patients achieved R0 resection during surgery

3. 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.)

4. 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.

Other Outcome Measures

1. Change in FDG-PET SUV Measures [Up to 14 days prior to surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Patients must be eligible for curative intent surgical resection.

2. 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.

3. No prior history of congestive heart failure - NYHA class I to IV or known DPD deficiency

4. No current grade 2, 3, or 4 of neuropathy.

5. No known hypersensitivity to epirubicin, oxaliplatin and cisplatin, capecitabine and 5-flurouracil, docetaxel or irinotecan.

6. 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).

1. Age ≥ 18 years

2. ECOG Performance Status 0 or 1

3. 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.

1. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles County-USC Medical Center	Los Angeles	California	United States	90033
2	USC / Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
3	Saint Helena Hospital	Saint Helena	California	United States	94574
4	Helen F Graham Cancer Center	Newark	Delaware	United States	19713
5	Medical Oncology Hematology Consultants PA	Newark	Delaware	United States	19713
6	Regional Hematology and Oncology PA	Newark	Delaware	United States	19713
7	Christiana Care Health System-Christiana Hospital	Newark	Delaware	United States	19718
8	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
9	Emory University/Winship Cancer Institute	Atlanta	Georgia	United States	30322
10	Hawaii Oncology Inc-Pali Momi	'Aiea	Hawaii	United States	96701
11	Hawaii Cancer Care Inc-POB II	Honolulu	Hawaii	United States	96813
12	Queen's Medical Center	Honolulu	Hawaii	United States	96813
13	Straub Clinic and Hospital	Honolulu	Hawaii	United States	96813
14	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii	United States	96817
15	Hawaii Oncology Inc-Kuakini	Honolulu	Hawaii	United States	96817
16	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii	United States	96817
17	Kootenai Cancer Center	Post Falls	Idaho	United States	83854
18	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
19	University of Chicago Comprehensive Cancer Center	Chicago	Illinois	United States	60637
20	Northwestern Medicine Cancer Center Delnor	Geneva	Illinois	United States	60134
21	Northwestern Medicine Cancer Center Warrenville	Warrenville	Illinois	United States	60555
22	Memorial Regional Cancer Center Day Road	Mishawaka	Indiana	United States	46545
23	Reid Health	Richmond	Indiana	United States	47374
24	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
25	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
26	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109
27	Fairview-Southdale Hospital	Edina	Minnesota	United States	55435
28	Abbott-Northwestern Hospital	Minneapolis	Minnesota	United States	55407
29	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216
30	Freeman Health System	Joplin	Missouri	United States	64804
31	Delbert Day Cancer Institute at PCRMC	Rolla	Missouri	United States	65401
32	Saint John's Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
33	Mercy Hospital Saint Louis	Saint Louis	Missouri	United States	63141
34	Mercy Hospital Springfield	Springfield	Missouri	United States	65804
35	CoxHealth South Hospital	Springfield	Missouri	United States	65807
36	Billings Clinic Cancer Center	Billings	Montana	United States	59101
37	Saint Vincent Healthcare	Billings	Montana	United States	59101
38	Bozeman Deaconess Hospital	Bozeman	Montana	United States	59715
39	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
40	Benefis Healthcare- Sletten Cancer Institute	Great Falls	Montana	United States	59405
41	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
42	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
43	Englewood Hospital and Medical Center	Englewood	New Jersey	United States	07631
44	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
45	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
46	Weill Medical College of Cornell University	New York	New York	United States	10065
47	Wayne Memorial Hospital	Goldsboro	North Carolina	United States	27534
48	Oncology Hematology Care Inc-Blue Ash	Cincinnati	Ohio	United States	45242
49	Good Samaritan Hospital - Dayton	Dayton	Ohio	United States	45406
50	Miami Valley Hospital	Dayton	Ohio	United States	45409
51	Samaritan North Health Center	Dayton	Ohio	United States	45415
52	Blanchard Valley Hospital	Findlay	Ohio	United States	45840
53	Atrium Medical Center-Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
54	Wayne Hospital	Greenville	Ohio	United States	45331
55	Kettering Medical Center	Kettering	Ohio	United States	45429
56	Springfield Regional Medical Center	Springfield	Ohio	United States	45505
57	Upper Valley Medical Center	Troy	Ohio	United States	45373
58	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
59	Providence Portland Medical Center	Portland	Oregon	United States	97213
60	Providence Saint Vincent Medical Center	Portland	Oregon	United States	97225
61	Medical University of South Carolina	Charleston	South Carolina	United States	29425
62	Greenville Health System Cancer Institute-Andrews	Greenville	South Carolina	United States	29605
63	Greenville Health System Cancer Institute-Butternut	Greenville	South Carolina	United States	29605
64	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina	United States	29605
65	Greenville Health System Cancer Institute-Eastside	Greenville	South Carolina	United States	29615
66	Greenville Health System Cancer Institute-Greer	Greer	South Carolina	United States	29650
67	Greenville Health System Cancer Institute-Seneca	Seneca	South Carolina	United States	29672
68	Greenville Health System Cancer Institute-Spartanburg	Spartanburg	South Carolina	United States	29307
69	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah	United States	84112
70	University of Vermont College of Medicine	Burlington	Vermont	United States	05405
71	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298

Sponsors and Collaborators

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

Investigators

• Study Chair: Manish Shah, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 15, 2016

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT02485834
• Other Study ID Numbers: A021302; U10CA180821; NCI-2014-02566
• First Posted: Jun 30, 2015
• Last Update Posted: Sep 11, 2019
• Last Verified: Sep 1, 2019

• Additional relevant MeSH terms: Adenocarcinoma; Stomach Neoplasms; Docetaxel; Capecitabine; Irinotecan

Study Results

Participant Flow

Pre-assignment Detail	Pre-randomization events included: 1) Baseline FDG-PET scan 2) Pre-registration 3) Second FDG-PET scan. Screen failures excluded from the study before randomization consisted of ineligible patients (n = 13), investigator decision (n = 1), and other screen failure reason (n=1).

Arm/Group Title	Arm A - Surgery, Chemotherapy and Radiation Therapy	Arm B - Surgery, Chemotherapy and FDG-PET
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	3	2
COMPLETED	3	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Randomized Patients
Arm/Group Description	Patients on Arms A and B as detailed in the Participant Flow are summarized.
Overall Participants	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.4 (7.4)
Sex: Female, Male (Count of Participants)
Female	2 40%
Male	3 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 20%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 20%
More than one race	0 0%
Unknown or Not Reported	3 60%
ECOG Performance Status (Count of Participants)
0	3 60%
1	2 40%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.

Arm/Group Title	Randomized Patients
Arm/Group Description	Patients on Arms A and B as detailed in the Participant Flow are summarized.
Measure Participants	5
Median (95% Confidence Interval) [months]	NA

2. Secondary Outcome

Title	Progression-free Survival
Description	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.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.

Arm/Group Title	Randomized Patients
Arm/Group Description	Patients on Arms A and B as detailed in the Participant Flow are summarized.
Measure Participants	5
Median (95% Confidence Interval) [months]	NA

3. Secondary Outcome

Title	Number of Patients Achieved R0 Resection During Surgery
Description	The number of patients achieved R0 resection during surgery
Time Frame	At time of surgery

Outcome Measure Data

Analysis Population Description

Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.

Arm/Group Title	Randomized Patients
Arm/Group Description	Patients on Arms A and B as detailed in the Participant Flow are summarized.
Measure Participants	5
Count of Participants [Participants]	3 60%

4. Secondary Outcome

Title	Number of Patients Had Pathologic Complete Response
Description	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.)
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.

Arm/Group Title	Randomized Patients
Arm/Group Description	Patients on Arms A and B as detailed in the Participant Flow are summarized.
Measure Participants	5
Count of Participants [Participants]	4 80%

5. Secondary Outcome

Title	Number of Participants Who Reported Grade 3 or Higher Adverse Events
Description	The number of patients who reported grade 3 or higher Adverse Events according to Common Terminology Criteria for Adverse Events version 4.0.
Time Frame	Up to 30 days after completion of protocol treatment

Outcome Measure Data

Analysis Population Description

Only patients who received treatment and were assessed for adverse events and completed the adverse events form were included in this analysis.

Arm/Group Title	Randomized Patients
Arm/Group Description	Patients on Arms A and B as detailed in the Participant Flow are summarized.
Measure Participants	4
Count of Participants [Participants]	3 60%

6. Other Pre-specified Outcome

Title	Change in FDG-PET SUV Measures
Time Frame	Up to 14 days prior to surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events are assessed prior to pre-registration, prior to registration, on day 1 of weeks 1 and 4 of chemo-radiation therapy for Arm A patients, on day 1 of each cycle (pre ad post-surgery) for Arm B patients, and prior to surgery for Arm A and B patients; Up to 30 days after completion of protocol treatment
Adverse Event Reporting Description	Each CTCAE term is a representation of a specific event used for medical documentation & analysis & is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients assessed for AEs and completed AE form. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, & appear in the SAE table.
Arm/Group Title	Arm A - Surgery, Chemotherapy and Radiation Therapy		Arm B - Surgery, Chemotherapy and FDG-PET
Arm/Group Description	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.		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.
All Cause Mortality
	Arm A - Surgery, Chemotherapy and Radiation Therapy		Arm B - Surgery, Chemotherapy and FDG-PET
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/2 (50%)		0/2 (0%)
Serious Adverse Events
	Arm A - Surgery, Chemotherapy and Radiation Therapy		Arm B - Surgery, Chemotherapy and FDG-PET
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		0/2 (0%)
Blood and lymphatic system disorders
Anemia	1/2 (50%)	1	0/2 (0%)	0
Gastrointestinal disorders
Abdominal pain	1/2 (50%)	1	0/2 (0%)	0
Dysphagia	1/2 (50%)	1	0/2 (0%)	0
Gastroesophageal reflux disease	1/2 (50%)	1	0/2 (0%)	0
Jejunal obstruction	1/2 (50%)	1	0/2 (0%)	0
Nausea	2/2 (100%)	2	0/2 (0%)	0
General disorders
Fatigue	2/2 (100%)	2	0/2 (0%)	0
Investigations
Weight loss	1/2 (50%)	1	0/2 (0%)	0
Metabolism and nutrition disorders
Anorexia	1/2 (50%)	1	0/2 (0%)	0
Musculoskeletal and connective tissue disorders
Generalized muscle weakness	1/2 (50%)	1	0/2 (0%)	0
Psychiatric disorders
Anxiety	1/2 (50%)	1	0/2 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm A - Surgery, Chemotherapy and Radiation Therapy		Arm B - Surgery, Chemotherapy and FDG-PET
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		2/2 (100%)
Blood and lymphatic system disorders
Anemia	0/2 (0%)	0	2/2 (100%)	2
Gastrointestinal disorders
Constipation	0/2 (0%)	0	1/2 (50%)	1
Diarrhea	0/2 (0%)	0	1/2 (50%)	1
Dysphagia	0/2 (0%)	0	1/2 (50%)	1
General disorders
Fatigue	0/2 (0%)	0	2/2 (100%)	3
Respiratory, thoracic and mediastinal disorders
Dyspnea	0/2 (0%)	0	1/2 (50%)	1
Skin and subcutaneous tissue disorders
Erythema multiforme	0/2 (0%)	0	1/2 (50%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.