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Esophageal CancerNCT00003381

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

An observational study of Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 44 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
How many people
56 participants
Where
44 sitesUnited States
Study dates
Jul 1998to Jan 2005
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with esophageal cancer eligible to participate in C9781.

  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.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Veterans Affairs Medical Center - Birmingham

    Birmingham, Alabama, 35233

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Veterans Affairs Medical Center - Buffalo

    Buffalo, New York, 14215

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • University of Illinois at Chicago Health Sciences Center

    Chicago, Illinois, 60612

  • Veterans Affairs Medical Center - Chicago (Westside Hospital)

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637

  • Veterans Affairs Medical Center - Columbia (Truman Memorial)

    Columbia, Missouri, 65201

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Veterans Affairs Medical Center - Durham

    Durham, North Carolina, 27705

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • CCOP - North Shore University Hospital

    Manhasset, New York, 11030

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Veterans Affairs Medical Center - Memphis

    Memphis, Tennessee, 38104

  • University of Tennessee, Memphis Cancer Center

    Memphis, Tennessee, 38163

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Presbyterian Hospital - Cornell Campus

    New York, New York, 10021

  • Mount Sinai Medical Center, NY

    New York, New York, 10029

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • MBCCOP - Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94115-0128

  • Veterans Affairs Medical Center - San Francisco

    San Francisco, California, 94121

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.

    Syracuse, New York, 13210

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Syracuse

    Syracuse, New York, 13210

  • Veterans Affairs Medical Center - Togus

    Togus, Maine, 04330

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • Veterans Affairs Medical Center - White River Junction

    White River Junction, Vermont, 05009

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - Southeast Cancer Control Consortium

    Winston-Salem, North Carolina, 27104-4241

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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]

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.

Read the 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.

Medical subject headings
Esophageal Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the quality of life of patients

    Measured: Up to 3 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2004 (estimated)
  2. Study startJul 1998
  3. Primary completionJan 2005
  4. Study completionJan 2005

Why it stopped: companion study to CALGB-9781 which closed administratively due to poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003381
Sponsor's protocol ID
CALGB-9870
Other IDs
CDR0000066376
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 44 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: companion study to CALGB-9781 which closed administratively due to poor accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the quality of life of patients (time frame: Up to 3 years post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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