Quality of Life Assessment of Patients Receiving Treatment for Esophageal Cancer [Companion to CALGB-9781]
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 |
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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
Outcome Measures
Primary Outcome Measures
- Evaluate the quality of life of patients [Up to 3 years post treatment]
Eligibility Criteria
Criteria
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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.
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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.
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Tumors had to be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases.
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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.
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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.
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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.
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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 | |
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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.- CALGB-9870
- CDR0000066376