Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier:
NCT00322634
First received: May 5, 2006
Last updated: September 17, 2012
Last verified: August 2011
  Purpose

The use of performance status and LDH in combination can predict patient survival more accurately than physician clinical impression or the patients' own feelings about their survival


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigator Initiated Trial: Prospective Study of Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by New Mexico Cancer Care Alliance:

Primary Outcome Measures:
  • Disease Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with incurable cancer frequently ask their doctors for an estimate of survival. Such estimates can assist patients in making decisions about how best to spend their time and energy. Survival estimates are also required when considering patients with incurable cancer for experimental treatments. However, such estimates are difficult to make. There is some data to suggest that a simple clinical measure, the performance status, combined with a laboratory blood test, the LDH, may assist in making the survival estimate more realistic. This study is designed to test if this is the case, using patients with metastatic lung, breast, colorectal, prostate, or pancreatic cancer or patients with cancer of unknown primary who have exhausted life-prolonging therapy. These patients will be asked to consent to entering this study. Their performance status will be assessed by the Karnofsky and WHO scales, they will be asked to have their blood tested for LDH and they and their doctor will be asked to estimate their survival. After study entry they will be allowed to receive palliative radiotherapy, surgery or systemic therapy as indicated including protocol treatment. After study entry, the only other requirement is that the date of the patients death be reported so that the duration of survival can be compared with the doctors and patients estimate and correlated with the performance status and LDH.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with metastatic solid tumors.

Criteria

Inclusion Criteria:

  1. All patients must be at least 18 years of age
  2. All patients must have documented incurable metastatic cancer
  3. All patients must have exhausted any treatments which are known to prolong survival in their disease, or have elected not to receive further life-prolonging therapy. Specifically, patients with the following are eligible:

    1. Non-small cell lung cancer patients after third systemic therapy
    2. Small cell lung cancer patients after second systemic therapy
    3. Breast cancer patients after third cytotoxic therapy (does not include hormonal therapy)
    4. Colorectal cancer patients after second systemic therapy
    5. Hormone refractory prostate cancer patients after first cytotoxic therapy
    6. Cancer of unknown primary
    7. Pancreatic cancer patients after first systemic therapy
  4. The use of systemic (chemotherapy, immunotherapy) or local treatments (XRT) for palliation of symptoms is allowed
  5. Patients with a history of previous cancers are allowed
  6. Patients with a history of other significant disease (e.g. heart disease, COPD, etc.) are allowed
  7. All patients must sign informed consent

Exclusion Criteria:

  1. Patients with acute or chronic leukemia, Hodgkin's disease, or non-Hodgkins lymphoma are excluded
  2. Patients who do not sign informed consent are excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322634

Locations
United States, New Mexico
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87102-3661
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Radiation Oncology Associates
Albuquerque, New Mexico, United States, 87111
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States, 87505
Sponsors and Collaborators
New Mexico Cancer Care Alliance
Investigators
Principal Investigator: Malcolm Purdy, MD Hematology Oncology Associates
  More Information

No publications provided

Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00322634     History of Changes
Other Study ID Numbers: INST 0535C
Study First Received: May 5, 2006
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 31, 2014