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Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

Randomized Phase II Trial of Extended Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia


OBJECTIVES:

Primary

- Assess and compare the pathologic complete response rate of sequential docetaxel,
oxaliplatin, and capecitabine followed by fluorouracil, oxaliplatin, and radiotherapy
versus fluorouracil, oxaliplatin, and radiotherapy alone in patients with potentially
resectable advanced adenocarcinoma of the esophagus, gastroesophageal junction, or
gastric cardia.

Secondary

- Assess the adverse event profile and safety of these regimens in this patient
population.

- Assess and compare the overall survival of patients treated with these regimens.

- Assess and compare the disease-free survival between treatment arms.

- Assess and compare the clinical tumor response rate of these proposed regimens when
administered before surgery between treatment arms.

- Evaluate the profiles of pharmacogenetic and proteomic marker measures over time, and
assess the association of changes in these biomarkers induced by these proposed
regimens with pathologic tumor response and other outcomes of interest.

- Evaluate the profiles of FDG PET/CT measures, including standardized uptake values and
% injected dose in the tumor volume over time, and assess the correlation of changes in
PET measures with pathologic tumor response and other outcomes of interest.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance
status (0-1 vs 2), and disease stage (II vs III/IVA). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day
1. Patients also receive oral capecitabine twice daily on days 1-14. Treatment repeats
every 21 days for 2 courses in the absence of disease progression or unacceptable
toxicity. After completion of the second course, patients receive fluorouracil* IV
continuously on days 1-5 and oxaliplatin IV over 2 hours on days 1, 15, and 29.
Patients also undergo radiotherapy** 5 days a week for 5.5 weeks in the absence of
disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion
of radiotherapy, patients undergo surgery.

- Arm II: Patients receive fluorouracil IV continuously on days 1-5 and oxaliplatin IV
over 2 hours on days 1, 15, and 29. Patients also undergo radiotherapy and then surgery
as in arm I.* NOTE: * Fluorouracil continuous IV infusion begins within 24 hours of
radiotherapy and ends within 24 hours of radiotherapy completion.

NOTE: ** Radiotherapy should begin within 2-6 weeks after completion of 2 courses of
docetaxel, oxaliplatin, and capecitabine.

Blood samples are collected at baseline and periodically during study for pharmacogenetic
(genetic polymorphisms along with drug target pathways) and proteomic markers (microRNA and
mRNA expression) studies. Tumor tissue samples from biopsy and surgery are also collected
for pharmacogenetic and proteomic markers studies and future correlative studies.

After completion of study therapy, patients are followed up every 3-6 months for 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed locally advanced adenocarcinoma of the esophagus,
gastroesophageal (GE) junction, or gastric cardia

- Surgically resectable disease

- T4N0M0 tumors that are potentially resectable allowed

- T1N0M0 or T2N0M0 tumors not allowed

- Nodal involvement:

- Involvement of celiac nodes (stations 15-20) allowed if the primary lesion is
mid-thoracic, distal esophagus, or GE junction

- Supraclavicular node involvement allowed with upper thoracic-esophagus primary
lesions

- No palpable supraclavicular nodes, biopsy-proven involvement of supraclavicular
nodes, or radiographically involved supraclavicular nodes (> 1.5 cm in greatest
dimension) for lesions in mid-thoracic, distal thoracic, or GE junction

- No evidence of distant metastases

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to swallow pills

- Willing to return to NCCTG enrolling institution for follow-up

- Willing to provide mandatory tissue and blood samples for research purposes

- Willing to undergo FDG PET/CT scans for mandatory research purposes

- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens

- Not immunocompromised unless related to the use of corticosteroids

- No known HIV positivity

- No uncontrolled intercurrent illness including, but not limited to, the following
conditions:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness and/or social situations that would limit compliance with
study requirements

- No uncontrolled diabetes

- No other active malignancy, except for non-melanoma skin cancer or carcinoma in-situ
of the cervix, unless curatively treated with no evidence of disease within the past
5 years and not on concurrent specific treatment for cancer other than hormonal
therapy

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to ≥ 30% of the marrow cavity

- No prior or other concurrent treatment for this malignancy

- No concurrent intensity-modulated radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate

Safety Issue:

No

Principal Investigator

Steven R. Alberts, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000646724

NCT ID:

NCT00938470

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Gastric Cancer
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the gastroesophageal junction
  • stage IIIA gastric cancer
  • stage IIIB gastric cancer
  • stage IIIC gastric cancer
  • stage IIIA esophageal cancer
  • stage IIIB esophageal cancer
  • stage IIIC esophageal cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Avera Cancer InstituteSioux Falls, South Dakota  57105
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
Hinsdale, Illinois  60521
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Wesley Medical CenterWichita, Kansas  67214
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Dakota Cancer Institute at Dakota Clinic - South UniversityFargo, North Dakota  58103-4940
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Poudre Valley HospitalFort Collins, Colorado  80524
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Eureka Community HospitalEureka, Illinois  61530
Mason District HospitalHavana, Illinois  62644
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Midelfort Clinic - LutherEau Claire, Wisconsin  54702
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Grant Medical Center Cancer CareColumbus, Ohio  43215
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Galesburg Clinic, PCGalesburg, Illinois  61401
Illinois CancerCare - BloomingtonBloomington%, Illinois  61701
Illinois CancerCare - CantonCanton, Illinois  61520
Illinois CancerCare - CarthageCarthage, Illinois  62321
Illinois CancerCare - EurekaEureka, Illinois  61530
Illinois CancerCare - GalesburgGalesburg, Illinois  61401
Illinois CancerCare - HavanaHavana, Illinois  62644
Illinois CancerCare - Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare - MacombMacomb, Illinois  61455
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
OSF Holy Family Medical CenterMonmouth, Illinois  61462
Illinois CancerCare - MonmouthMonmouth, Illinois  61462
Illinois CancerCare - Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare - PeruPeru, Illinois  61354
Illinois CancerCare - PrincetonPrinceton, Illinois  61356
Mercy General Health PartnersMuskegon, Michigan  49443
AnMed Cancer CenterAnderson, South Carolina  29621
Luther Midlelfort HospitalEau Claire, Wisconsin  54702
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
St. Nicholas HospitalSheboygan, Wisconsin  53081
Door County Cancer Center at Door County Memorial HospitalSturgeon Bay, Wisconsin  54235-1495
Central Care Cancer Center at Carrie J. Babb Cancer CenterBolivar, Missouri  65613
Spectrum Health Reed City HospitalReed City, Michigan  49677
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700