Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Deborah Citrin, M.D., National Institutes of Health Clinical Center (CC) Identifier:
First received: October 25, 2007
Last updated: September 29, 2015
Last verified: September 2015

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.

Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Metastatic Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Other: questionnaire administration
Radiation: 3-dimensional conformal radiation therapy
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: tomotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Local control (e.g. absence of local progression) is defined as Complete response (CR), partial response (PR) or stable disease (SD) of the treated site(s). Complete response is the disappearance of the target lesion. Partial response is a >/= 50% decrease in maximal dimension compared to pretreatment imaging. Stable disease does not qualify for CR, PR, or progression.Progression is an interval increase in the maximal dimension of the target lesion.

Secondary Outcome Measures:
  • Number of Participants With Adverse Events [ Time Frame: 9 months, 11 days ] [ Designated as safety issue: Yes ]
    Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Enrollment: 1
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: questionnaire administration
Patients complete a pain assessment questionnaire, Brief Pain Inventory at baseline and at 1 and 3 months after treatment.
Other Name: Brief Pain Inventory
Radiation: 3-dimensional conformal radiation therapy
Conformal radiation therapy improves the ability to spare normal tissues.
Radiation: hypofractionated radiation therapy
Hypofractionated radiation therapy is delivered to maximize pain relief while minimizing patient impact if life expectancy is short.
Radiation: image-guided radiation therapy
Image guided radiation therapy targets the specific site of disease.
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.

Detailed Description:



  • 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.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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)
      • Carbon monoxide diffusing capacity (DLCO) > 30% predicted and forced expiratory volume 1 (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


  • 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


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00550654

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Principal Investigator: Deborah E. Citrin, MD NCI - Radiation Oncology Branch; ROB
  More Information

Responsible Party: Deborah Citrin, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC) Identifier: NCT00550654     History of Changes
Other Study ID Numbers: 070230  NCI-07-C-0230 
Study First Received: October 25, 2007
Results First Received: August 20, 2012
Last Updated: September 29, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
unspecified adult solid tumor, protocol specific
recurrent adult soft tissue sarcoma
recurrent melanoma
recurrent osteosarcoma
recurrent renal cell cancer
recurrent uterine sarcoma
stage IV adult soft tissue sarcoma
stage IV melanoma
stage IV uterine sarcoma
ovarian sarcoma
metastatic osteosarcoma
stage IV renal cell cancer
lung metastases
liver metastases
bone metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Kidney Neoplasms
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Connective and Soft Tissue
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial processed this record on December 07, 2016