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OpenTrials
Completed

NCT Number: NCT00322634

Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hematology Oncology Associates, Albuquerque, New Mexico, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients must be at least 18 years of age
  • All patients must have documented incurable metastatic cancer
  • 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:
  • Non-small cell lung cancer patients after third systemic therapy
  • Small cell lung cancer patients after second systemic therapy
  • Breast cancer patients after third cytotoxic therapy (does not include hormonal therapy)
  • Colorectal cancer patients after second systemic therapy
  • Hormone refractory prostate cancer patients after first cytotoxic therapy
  • Cancer of unknown primary
  • Pancreatic cancer patients after first systemic therapy
  • The use of systemic (chemotherapy, immunotherapy) or local treatments (XRT) for palliation of symptoms is allowed
  • Patients with a history of previous cancers are allowed
  • Patients with a history of other significant disease (e.g. heart disease, COPD, etc.) are allowed
  • All patients must sign informed consent

Exclusion criteria

  • Patients with acute or chronic leukemia, Hodgkin's disease, or non-Hodgkins lymphoma are excluded
  • Patients who do not sign informed consent are excluded

Treatment and study plan

Primary outcomes

  1. Disease Progression

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

New Mexico Cancer Research Alliance

Other

Registry information

Official study title

Investigator Initiated Trial: Prospective Study of Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
May 8, 2006
Registry last updated
Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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