Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain

NCT ID: NCT00550654

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-05-31

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This phase II trial is studying how well conformal radiation therapy works in treating patients with metastatic cancer outside the brain.

Detailed Description

OBJECTIVES:

Primary

• To evaluate local control (defined as absence of local progression) at all treated sites of metastatic disease in patients with extracranial oligometastases treated with ablative doses of highly conformal radiotherapy delivered with helical tomotherapy.
• To evaluate local control at each treated site of metastatic disease in these patients.

Secondary

• To determine median time to local progression in patients treated with this regimen.
• To evaluate interfraction and intrafraction motion with megavoltage computed tomography (CT) imaging based on site of metastasis in these patients.
• To compare tumor growth during systemic therapy in tumors treated with targeted radiotherapy vs newly developed tumors that have not been treated with radiotherapy.
• To evaluate if treatment with hypofractionated highly conformal radiotherapy with helical tomotherapy can improve pain scores and decrease the need for analgesia in these patients.

OUTLINE: Patients are stratified according to histology (renal cell carcinoma vs melanoma vs sarcoma vs other histologies).

Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions. Patients undergo megavoltage imaging before and after each fraction to verify the positioning of each target lesion.

Patients complete a pain assessment questionnaire at baseline and at 1 and 3 months after treatment.

After completion of study therapy, patients are followed at 1 and 3 months and then every 3 months for up to 1 year.

Conditions

Kidney Cancer; Melanoma (Skin); Metastatic Cancer; Ovarian Cancer; Sarcoma; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Therapy in Metastatic Cancer

Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Conformal radiation therapy improves the ability to spare normal tissues.

hypofractionated radiation therapy

Intervention Type: RADIATION

Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.

image-guided radiation therapy

Intervention Type: RADIATION

Image guided radiation therapy targets the specific site of disease.

tomotherapy

Intervention Type: RADIATION

Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.

Interventions

questionnaire administration

Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.

Intervention Type: OTHER

3-dimensional conformal radiation therapy

Conformal radiation therapy improves the ability to spare normal tissues.

Intervention Type: RADIATION

hypofractionated radiation therapy

Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.

Intervention Type: RADIATION

image-guided radiation therapy

Image guided radiation therapy targets the specific site of disease.

Intervention Type: RADIATION

tomotherapy

Tomotherapy is a delivery method which provides megavoltage computed tomography (CT) localization and may provide superior conformality and localization compared to other dynamic intensity modulated radiation therapy techniques.

Intervention Type: RADIATION

Other Intervention Names

Brief Pain Inventory

Eligibility Criteria

Exclusion Criteria

• Proposed site(s) of treatment has been previously treated with radiotherapy
• Metastatic site(s) requires emergent treatment (e.g., spinal cord compression, cauda equina, airway compromise, or life-threatening end-organ dysfunction)
• Disease that is untreated or previously treated and progressive in the brain
• Pathologic fracture or impending pathologic fracture at the metastatic site
• Metastatic site(s) of a disease histology that is known to be sensitive to low doses of radiotherapy (e.g., pure seminoma, lymphoma, or small cell carcinoma)
• Patients in whom surgery is deemed an appropriate option as standard of care (e.g., isolated lung metastasis from sarcoma or isolated liver metastasis from colon cancer) but who refuse surgical therapy are eligible

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy > 12 weeks as assessed by the consulting radiation oncologist
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No history of lupus erythematosus or scleroderma
• No known hypersensitivity to therapeutic radiotherapy
• No other malignancy within the past 2 years except nonmelanoma skin cancer or in situ malignancies of the cervix, bladder, or head and neck
• No unrelated systemic illness that, in the judgment of the investigator, would compromise the patient's ability to tolerate study therapy or would likely interfere with study procedures or results
• Able or likely to adhere to study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 2 weeks since prior and no concurrent chemotherapy
• Prior or concurrent hormonal agents, including antiandrogens, gonadotropin-releasing hormone agonists, aromatase inhibitors, tamoxifen, or similar agents allowed
• No change in systemic therapy for 6 weeks before or within 4 weeks after initiating study radiotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role: lead

Responsible Party

Deborah Citrin, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah E. Citrin, MD

Role: PRINCIPAL_INVESTIGATOR

NCI - Radiation Oncology Branch; ROB

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-07-C-0230

Identifier Type: -

Identifier Source: secondary_id

070230

Identifier Type: -

Identifier Source: org_study_id