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A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer

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Trial Information

A Prospective Randomized Phase III Trial Comparing Trimodality Therapy (Cisplatin, 5-FU, Radiotherapy, and Surgery) to Surgery Alone for Esophageal Cancer


OBJECTIVES: I. Compare overall five-year survival rates and treatment failures in patients
receiving neoadjuvant cisplatin (CDDP) plus fluorouracil (5-FU) with concomitant
radiotherapy followed by surgical resection versus patients receiving surgery alone. II.
Assess and compare the toxicities of each approach. III. Compare the incidence and pattern
of local (gastric or esophageal bed or regional lymph nodes) and distant (supraclavicular
lymph node, liver, peritoneal carcinomatosis, or lung, brain, etc.) recurrence. IV. Evaluate
the prognostic ability of noninvasive and minimally invasive pretreatment staging with
regard to survival and recurrence. V. Evaluate the ability of preresection adjuvant
chemotherapy with concomitant radiation therapy to render tumors to lower stages. VI.
Evaluate the impact of lymph nodes on survival and recurrence.

OUTLINE: This a two arm, randomized study. Patients are stratified by: cell type of cancer
(squamous cell vs adenocarcinoma); lymph nodes (positive vs negative); and stage (invasive
vs noninvasive). Patients in arm I undergo chemotherapy and radiotherapy within 24 hours of
each other. Chemotherapy consists of cisplatin (CDDP) by bolus IV infusion over 30 minutes
on day 1 and again on day 29. Fluorouracil (5-FU) is administered by continuous IV infusion
for 4 days (on days 1-4 and 29-32) after completion of cisplatin. Radiotherapy is
administered on days 1-5, 8-12, 15-19, 22-26, and 29-33, with a boost on days 36-38. If
there is no disease progression or unresectable disease, surgery is performed within 3-8
weeks following completion of therapy. Patients in arm II undergo surgery alone no later
than 6 weeks postrandomization. Patients are followed at least every 3 months for two years,
then every 6 months for the next two years, and annually thereafter.

PROJECTED ACCRUAL: There will be 500 patients accrued into this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma or
adenocarcinoma of the thoracic esophagus or gastroesophageal junction Stages I, IIA, IIB,
or III Tumor must be considered surgically resectable No positive supraclavicular nodes
(greater than 1.5 cm by CT) or palpable supraclavicular nodes No positive (greater than
1.5 cm by CT) nodes in levels 15-20 Lymph node involvement in levels 15, 16, and 20 that
are no greater than 1.5 cm by CT allowed Patient without radiographical evidence of lymph
node involvement in levels 15, 16, and 20 that are proven positive at time of presurgical
staging also allowed Radiographically positive lymph node involvement in levels 17-19
allowed only if proven to be negative by biopsy No positive lymph node involvement in
levels 17-19 even if there was no radiographic evidence of lymph node involvement No
tumors with greater than 2 cm distal spread into the gastric cardia No distant metastases
(suspicious lesions on CT should be tested by ultrasound, MRI or biopsy)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,800/mm3
Platelet count at least 100,000/mm3 Hepatic: If alkaline phosphatase is greater than 3
times normal, must undergo esophagoscopy with biopsy, barium esophagogram, CT scan of the
chest and upper abdomen, and bone scan Renal: Creatinine clearance at least 50 mL/min
Other: No other prior malignancy unless disease free for greater than 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for this malignancy Endocrine therapy: Not specified Radiotherapy: No prior
radiotherapy that would overlap the field(s) treated in this study Surgery: Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mark J. Krasna, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065873

NCT ID:

NCT00003118

Start Date:

October 1997

Completion Date:

March 2000

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503