Know Cancer

forgot password

A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus

Phase 2
18 Years
Open (Enrolling)
Esophageal Cancer

Thank you

Trial Information

A Phase II Study Of Paclitaxel-Based Chemoradiotherapy Regimen With Selective Surgical Salvage For Resectable Locoregionally Advanced Carcinoma Of The Esophagus


- Determine the feasibility of treatment with paclitaxel, cisplatin, and fluorouracil
followed by chemoradiotherapy and possible surgical salvage in patients with resectable
locally advanced carcinoma of the esophagus or gastroesophageal junction.

- Determine the overall and disease-free survival of patients treated with this regimen.

- Determine the treatment-related toxicity of this regimen in these patients.

- Determine the tolerance to surgical salvage in patients treated with this regimen.

- Determine the morbidity and mortality of surgical salvage in patients treated with this

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive fluorouracil (5-FU) IV continuously over 96 hours
beginning on days 1 and 29; cisplatin IV over 1 hour on days 1-5 and 29-33; paclitaxel
IV over 2 hours on days 1 and 29; and pegfilgrastim subcutaneously (SC) on days 6 and
34 OR filgrastim (G-CSF) SC on days 6-15 and 34-42. Treatment continues in the absence
of unacceptable toxicity.

- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 57-61 and 5-FU IV
continuously on days 57-61, 64-68, 71-75, 78-82, 85-89, and 92-96. Patients
concurrently undergo external beam radiotherapy on days 57-61, 64-68, 71-75, 78-82,
85-89, and 92-96.

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

Patients are followed periodically.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.

Inclusion Criteria


- Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus
or gastroesophageal junction

- Primary (non-recurrent) disease

- Amenable to resection

- Stage greater than T1, N0 by endoscopic ultrasound

- Must be entirely confined to the esophagus or gastroesophageal junction and
periesophageal soft tissue

- Tumor may not extend more than 2 cm into the stomach

- No multiple primary carcinomas of the esophagus

- No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus

- No evidence of disseminated cancer

- Suggestion of liver metastases by positron emission tomography must be proven
negative by biopsy or other imaging studies

- Palpable supraclavicular nodes must be negative for cancer by biopsy

- Bronchoscopy required for lesions less than 26 cm from the incisors to exclude
tracheoesophageal fistula or invasion

- No celiac adenopathy greater than 2 cm



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 150,000/mm^3

- Hemoglobin at least 10 g/dL


- Not specified


- Creatinine no greater than 1.5 mg/dL AND/OR

- Creatinine clearance at least 65 mL/min

- Calcium no greater than 11 mg/dL


- No uncontrolled heart disease

- No uncontrolled hypertension


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to comprehend study requirements and considered likely to comply with study

- No other malignancy within the past 5 years except curable nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No uncontrolled diabetes

- No hypersensitivity to E. coli-derived products


Biologic therapy

- Not specified


- More than 5 years since prior systemic chemotherapy

Endocrine therapy

- Not specified


- No prior chest or upper abdomen radiotherapy


- No prior esophageal or gastric surgery


- No concurrent photodynamic therapy

- No other concurrent investigational agents for esophageal carcinoma

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival rate at 1 year

Safety Issue:


Principal Investigator

Stephen G. Swisher, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • adenocarcinoma of the esophagus
  • squamous cell carcinoma of the esophagus
  • stage II esophageal cancer
  • stage III esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



Akron City Hospital Akron, Ohio  44304
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Foote Hospital Jackson, Michigan  49201
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Seton Cancer Institute - Saginaw Saginaw, Michigan  48601
St. John Macomb Hospital Warren, Michigan  48093
Fairview Ridges Hospital Burnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids, Minnesota  55433
Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse, Wisconsin  54601
CCOP - Ochsner New Orleans, Louisiana  70121
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
Gulf Coast Cancer Treatment Center Panama City, Florida  32405-4587
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
Albert Einstein Cancer Center Philadelphia, Pennsylvania  19141
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
LDS Hospital Salt Lake City, Utah  84143
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Monmouth Medical Center Long Branch, New Jersey  07740-6395
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
SUNY Downstate Medical Center Brooklyn, New York  11203
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Fox Chase Virtua Health Cancer Program - Marlton Marlton, New Jersey  08053
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
CCOP - Nevada Cancer Research Foundation Las Vegas, Nevada  89109-2306
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Summit Medical Center Oakland, California  94609
Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
University Medical Center of Southern Nevada Las Vegas, Nevada  89102
Saint Rose Hospital Hayward, California  94545
Valley Care Medical Center Pleasanton, California  94588
J.C. Robinson, M.D. Regional Cancer Center San Pablo, California  94806
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Ochsner Clinic of Baton Rouge Baton Rouge, Louisiana  708169990
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital Ann Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron Mountain Iron Mountain, Michigan  49801
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale, Minnesota  55422-2900
Park Nicollet Health Services St. Louis Park, Minnesota  55416
Hattiesburg Clinic, P.A. Hattiesburg, Mississippi  39401
Booker Cancer Center at Riverview Medical Center Red Bank, New Jersey  07701
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Delaware County Regional Cancer Center at Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Green Bay Oncology, Limited at St. Vincent Hospital Green Bay, Wisconsin  54301-3526
Rose Ramer Cancer Clinic at Anderson Area Medical Center Anderson, South Carolina  29621
Providence Holy Cross Cancer Center Mission Hills, California  91346-9600
Wendt Regional Cancer Center at Finley Hospital Dubuque, Iowa  52001
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford Salem, Ohio  44460
Cancer Treatment Center Wooster, Ohio  44691
Schiffler Cancer Center at Wheeling Hospital Wheeling, West Virginia  26003
Hospital of Saint Raphael New Haven, Connecticut  06511
Albuquerque Regional Medical Center at Lovelace Sandia Health System Albuquerque, New Mexico  87102
Rutherford Hospital Rutherfordton, North Carolina  28139
Wilmed Radiation Oncology Services Wilson, North Carolina  27893
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Community Regional Cancer Center at Community Medical Center Toms River, New Jersey  08755
Mount Sinai Hospital Medical Center Chicago, Illinois  60608