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Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors


Phase 2
N/A
N/A
Not Enrolling
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors


OBJECTIVES:

- Determine the feasibility of fractionated stereotactic body radiosurgery in patients
with advanced extracranial tumors.

- Assess the toxicities of this treatment regimen in these patients.

- Determine tumor response and cause of death in these patients treated with this
regimen.

OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for
5-10 days for a total of 3 treatments.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed malignancy

- Extracranial recurrent or metastatic disease or primary tumor not predicted to
be controlled with standard radiotherapy

- Incurable with any standard therapy

- No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or
heart)

- Tumor visible by CT scan

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin less than 2.0 times upper limit of normal (ULN)

- AST and ALT less than 5 times ULN

Renal:

- Creatinine less than 2.0 mg/dL

Pulmonary:

- FEV1 greater than 0.75 L

Other:

- No unsuitable size or geometric proportion that would preclude stereotactic
immobilization

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 14 days since prior anticancer biologic therapy and recovered

Chemotherapy:

- At least 14 days since prior anticancer chemotherapy and recovered

Endocrine therapy:

- At least 14 days since prior anticancer endocrine therapy and recovered

Radiotherapy:

- See Disease Characteristics

- At least 14 days since prior anticancer radiotherapy and recovered

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Danny Y. Song, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massey Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068151

NCT ID:

NCT00006456

Start Date:

February 1999

Completion Date:

November 2004

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • lung metastases
  • liver metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Massey Cancer CenterRichmond, Virginia  23298-0037