Know Cancer

or
forgot password

Quality of Life and Cost Analysis of a Prospective Randomized Phase III Trial Comparing Trimodality Therapy to Surgery Alone for Esophageal Cancer


N/A
18 Years
N/A
Not Enrolling
Both
Psychosocial Effects of Cancer and Its Treatment

Thank you

Trial Information

Quality of Life and Cost Analysis of a Prospective Randomized Phase III Trial Comparing Trimodality Therapy to Surgery Alone for Esophageal Cancer


OBJECTIVES: I. Evaluate the quality of life of patients with esophageal cancer randomized on
protocol CALGB C9781 to treatment with surgery alone vs trimodal therapy combining
preoperative chemotherapy and radiation therapy in addition to surgery. II. Examine the
incremental cost and cost effectiveness of preoperative chemotherapy and radiation therapy
in the treatment of esophageal cancer. III. Examine the incremental cost per
quality-adjusted life year (QALY) of preoperative chemotherapy and radiation therapy in the
treatment of esophageal cancer.

OUTLINE: This is a companion study to CALGB C9781, a phase III randomized study. Prior to
treatment on CALGB C9781, patients complete forms assessing quality of life, psychological
functioning, specific areas of dysfunction, resource use, and time lost from work;
subsequent assessments are completed by telephone interview at 1, 2, 6, 12, 18, and 24
months after the initiation of study treatment, regardless of disease status (patients with
hearing impairment and those speaking only a translatable foreign language may mail
responses). Patients also keep a diary of medical resource utilization at sites other than
the treating institution.

PROJECTED ACCRUAL: Approximately 180 patients will be accrued to this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Patients with esophageal cancer enrolled on protocol CALGB-C9781

PATIENT CHARACTERISTICS: Age: 18 and over Patient able to communicate in English or
Spanish

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

David G. Pfister, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066376

NCT ID:

NCT00003381

Start Date:

July 1998

Completion Date:

Related Keywords:

  • Psychosocial Effects of Cancer and Its Treatment
  • psychosocial effects of cancer and its treatment
  • Esophageal Neoplasms

Name

Location

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
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
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of Illinois at Chicago Health Sciences CenterChicago, Illinois  60612
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705