Clinical Predictors of Survival in Cancer Patients With Metastatic Solid Tumors

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322634
• Other study ID #: INST 0535C
• Status: Completed
• Phase: N/A
• First received: May 5, 2006
• Last updated: September 17, 2012
• Start date: February 2006
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
United States	Hematology Oncology Associates	Albuquerque	New Mexico
United States	Radiation Oncology Associates	Albuquerque	New Mexico
United States	University of New Mexico	Albuquerque	New Mexico
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	St. Vincent Regional Medical Center	Santa Fe	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Progression		2 years	No