Combination Chemotherapy Followed By Chemoradiotherapy, With or Without Surgery, in Treating Patients With Resectable Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

PHASE2CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

September 30, 2003

Primary Completion Date

March 31, 2007

Study Completion Date

December 31, 2016

Conditions
Esophageal Cancer
Interventions
BIOLOGICAL

filgrastim

During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients \>70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42.

BIOLOGICAL

pegfilgrastim

During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34.

DRUG

cisplatin

During induction therapy, patients receive 15 mg/m\^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m\^2/day by IV over 1 hour beginning on days 57-61.

DRUG

fluorouracil

During induction therapy, patients receive 650 mg/m\^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m\^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles.

DRUG

paclitaxel

During induction therapy, patients receive 200 mg/m\^2/day by IV over 2 hours on days 1 and 29.

PROCEDURE

conventional surgery

Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.

RADIATION

radiation therapy

External beam radiotherapy with megavoltage linear accelerators (\> 6 MV) will be used to deliver multiple (\> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy.

Trial Locations (97)

11203

SUNY Downstate Medical Center, Brooklyn

19010

Bryn Mawr Hospital, Bryn Mawr

19026

Delaware County Regional Cancer Center at Delaware County Memorial Hospital, Drexel Hill

19096

CCOP - MainLine Health, Wynnewood

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

19141

Albert Einstein Cancer Center, Philadelphia

26003

Schiffler Cancer Center at Wheeling Hospital, Wheeling

27534

Wayne Memorial Hospital, Incorporated, Goldsboro

Wayne Radiation Oncology, Goldsboro

27893

Wilmed Radiation Oncology Services, Wilson

28139

Rutherford Hospital, Rutherfordton

29303

CCOP - Upstate Carolina, Spartanburg

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg

29621

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson

32405

Gulf Coast Cancer Treatment Center, Panama City

33176

Baptist-South Miami Regional Cancer Program, Miami

39401

Hattiesburg Clinic, P.A., Hattiesburg

44460

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem

44691

Cancer Treatment Center, Wooster

45044

Middletown Regional Hospital, Middletown

45385

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia

45405

Grandview Hospital, Dayton

45406

Good Samaritan Hospital, Dayton

45409

David L. Rike Cancer Center at Miami Valley Hospital, Dayton

45415

Samaritan North Cancer Care Center, Dayton

45428

Veterans Affairs Medical Center - Dayton, Dayton

45429

CCOP - Dayton, Dayton

Charles F. Kettering Memorial Hospital, Kettering

46107

St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove

48093

St. John Macomb Hospital, Warren

48106

CCOP - Michigan Cancer Research Consortium, Ann Arbor

48236

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods

48503

Genesys Hurley Cancer Institute, Flint

48601

Seton Cancer Institute - Saginaw, Saginaw

48909

Sparrow Regional Cancer Center, Lansing

49201

Foote Hospital, Jackson

49431

Green Bay Oncology, Limited - Escanaba, Escanaba

49801

Green Bay Oncology, Limited - Iron Mountain, Iron Mountain

52001

Wendt Regional Cancer Center at Finley Hospital, Dubuque

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54154

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls

54235

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay

54303

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay

St. Mary's Hospital Medical Center - Green Bay, Green Bay

54601

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse

55102

United Hospital, Saint Paul

55337

Fairview Ridges Hospital, Burnsville

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

Park Nicollet Health Services, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

60608

Mount Sinai Hospital Medical Center, Chicago

63110

Siteman Cancer Center at Barnes-Jewish Hospital, St Louis

65802

CCOP - Cancer Research for the Ozarks, Springfield

65804

St. John's Regional Health Center, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

70121

CCOP - Ochsner, New Orleans

80045

University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84107

Cottonwood Hospital Medical Center, Murray

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84403

McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center - Provo, Provo

84770

Dixie Regional Medical Center - East Campus, St. George

87102

Albuquerque Regional Medical Center at Lovelace Sandia Health System, Albuquerque

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

91505

Providence Saint Joseph Medical Center - Burbank, Burbank

94545

Saint Rose Hospital, Hayward

94588

Valley Care Medical Center, Pleasanton

94609

CCOP - Bay Area Tumor Institute, Oakland

Summit Medical Center, Oakland

94806

J.C. Robinson, M.D. Regional Cancer Center, San Pablo

708169990

Ochsner Clinic of Baton Rouge, Baton Rouge

91346-9600

Providence Holy Cross Cancer Center, Mission Hills

06511

Hospital of Saint Raphael, New Haven

31403-3089

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah

48106-0995

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor

48123-2500

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn

55422-2900

Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale

07740-6395

Monmouth Medical Center, Long Branch

08053

Fox Chase Virtua Health Cancer Program - Marlton, Marlton

07701

Booker Cancer Center at Riverview Medical Center, Red Bank

08755

Community Regional Cancer Center at Community Medical Center, Toms River

87131-5636

University of New Mexico Cancer Research and Treatment Center, Albuquerque

44309-2090

Akron City Hospital, Akron

45373-1300

UVMC Cancer Care Center at Upper Valley Medical Center, Troy

19301-1792

Paoli Memorial Hospital, Paoli

19107-5541

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia

19111-2497

Fox Chase Cancer Center, Philadelphia

77030-4009

M.D. Anderson Cancer Center at University of Texas, Houston

54301-3526

Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

NRG Oncology

OTHER

lead

Radiation Therapy Oncology Group

NETWORK