Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	NCI	NCI-07-C-0230 07-C-0230, NCT00550654

Special Category: NIH Clinical Center trial, NCI Web site featured trial

Objectives

Primary

1. 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.
2. To evaluate local control at each treated site of metastatic disease in these patients.

Secondary

1. To determine median time to local progression in patients treated with this regimen.
2. To evaluate interfraction and intrafraction motion with megavoltage CT imaging based on site of metastasis in these patients.
3. To compare tumor growth during systemic therapy in tumors treated with targeted radiotherapy vs newly developed tumors that have not been treated with radiotherapy.
4. 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.

Entry Criteria

Disease Characteristics:

• Pathologically confirmed cancer
  • No active disease at the primary site as assessed by physical examination, clinical evaluation, or site-specific imaging



• Measurable metastatic disease meeting the following criteria:
  • Four or fewer sites of extracranial lesions < 5 cm in size
  • If metastatic site(s) is within the lung, the following criteria must be met:
    • No more than two metastases in the proximal bronchial tree area (defined as 2 cm from the trachea or mainstem bronchi)
    • DLCO > 30% predicted and FEV1 > 1.2 L (in patients with more than one metastatic site in the lungs)
  • If metastatic site(s) is within 2 cm of either kidney, creatinine level must be < 1.5 times upper limit of normal (ULN)
  • If metastatic site(s) is within 2 cm of the liver, bilirubin level must be < 1.5 times ULN



• Patients with metastatic disease that meets any of the following criteria are excluded:
  • 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

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

Patient Characteristics:

• 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

Expected Enrollment

Outcomes

6-month local control (i.e., complete response, partial response, or stable disease) at all treated sites of metastatic disease
6-month local control at each treated site of metastatic disease

Median time to local progression
1-year local control at all treated sites of metastatic disease and at each treated site of metastatic disease
Interfraction and intrafraction motion based on site of metastasis
Alleviation of pain at sites of metastases as measured by the Brief Pain Inventory at 1 and 3 months after treatment
Comparison of tumor doubling times during systemic treatment in tumors treated with radiotherapy vs newly developed tumors that have not been treated with radiotherapy

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Deborah Citrin, MD, Principal investigator		Ph: 301-496-5457 Email: citrind@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Study of Hypofractionated Highly Conformal Radiation with Helical Tomotherapy for Extra-Cranial Oligo
Trial Start Date		2007-10-02
Trial Completion Date		2012-10-02 (estimated)
Registered in ClinicalTrials.gov		NCT00550654
Date Submitted to PDQ		2007-10-02
Information Last Verified		2008-11-30