Quality of Life Assessment of Patients Receiving Treatment for Esophageal Cancer [Companion to CALGB-9781]

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Terminated
CT.gov ID
NCT00003381
Collaborator
National Cancer Institute (NCI) (NIH)
56
44
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1.3
0

Study Details

Study Description

Brief Summary

RATIONALE: Questionnaires that measure quality of life during treatment may improve the ability to plan treatment for patients with esophageal cancer.

PURPOSE: This clinical trial is studying the quality of life in patients receiving treatment for esophageal cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    56 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Quality of Life and Cost Analysis of a Prospective Randomized Phase III Trial Comparing Trimodality Therapy to Surgery Alone for Esophageal Cancer [Companion to CALGB-9781]
    Study Start Date :
    Jul 1, 1998
    Actual Primary Completion Date :
    Jan 1, 2005
    Actual Study Completion Date :
    Jan 1, 2005

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate the quality of life of patients [Up to 3 years post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    1. Patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction and with less than 2cmdistal spread into the gastric cardia eligible for C9781.

    2. There could be no evidence of distant metastatic disease by history and physical examination; upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies were all required.

    3. Tumors had to be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases.

    4. Patients with supraclavicular lymph nodes measuring ≤1.5 cm by CT (not palpable) were eligible, as were patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤ 1.5 cm by CT.

    5. Patients could not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. Patients with previous malignancies were eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence.

    6. There could be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent.

    7. Patients with uncontrolled or severe cardiovascular disease, pulmonary disease, or active infections were excluded, as were pregnant patients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Affairs Medical Center - Birmingham Birmingham Alabama United States 35233
    2 University of California San Diego Cancer Center La Jolla California United States 92093-0658
    3 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94115-0128
    4 Veterans Affairs Medical Center - San Francisco San Francisco California United States 94121
    5 CCOP - Christiana Care Health Services Wilmington Delaware United States 19899
    6 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    7 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    8 University of Illinois at Chicago Health Sciences Center Chicago Illinois United States 60612
    9 Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois United States 60612
    10 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    11 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    12 Veterans Affairs Medical Center - Togus Togus Maine United States 04330
    13 Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    14 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    15 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    16 Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota United States 55417
    17 Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri United States 65201
    18 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    19 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    20 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    21 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    22 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756
    23 Veterans Affairs Medical Center - Buffalo Buffalo New York United States 14215
    24 CCOP - North Shore University Hospital Manhasset New York United States 11030
    25 North Shore University Hospital Manhasset New York United States 11030
    26 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    27 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021
    28 Mount Sinai Medical Center, NY New York New York United States 10029
    29 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13210
    30 State University of New York - Upstate Medical University Syracuse New York United States 13210
    31 Veterans Affairs Medical Center - Syracuse Syracuse New York United States 13210
    32 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    33 Veterans Affairs Medical Center - Durham Durham North Carolina United States 27705
    34 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    35 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    36 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157-1082
    37 Rhode Island Hospital Providence Rhode Island United States 02903
    38 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    39 Veterans Affairs Medical Center - Memphis Memphis Tennessee United States 38104
    40 University of Tennessee, Memphis Cancer Center Memphis Tennessee United States 38163
    41 Vermont Cancer Center Burlington Vermont United States 05401-3498
    42 Veterans Affairs Medical Center - White River Junction White River Junction Vermont United States 05009
    43 Veterans Affairs Medical Center - Richmond Richmond Virginia United States 23249
    44 MBCCOP - Massey Cancer Center Richmond Virginia United States 23298-0037

    Sponsors and Collaborators

    • Alliance for Clinical Trials in Oncology
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: David G. Pfister, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alliance for Clinical Trials in Oncology
    ClinicalTrials.gov Identifier:
    NCT00003381
    Other Study ID Numbers:
    • CALGB-9870
    • CDR0000066376
    First Posted:
    Jun 16, 2004
    Last Update Posted:
    Jul 6, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2016