Clinical trial NCT00550654: Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain
Official title: A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Cancer
Melanoma (Skin)
Metastatic Cancer
Ovarian Cancer
Sarcoma
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: 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
chondrosarcoma
metastatic osteosarcoma
stage IV renal cell cancer
lung metastases
liver metastases
bone metastases
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-10-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)
    * 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

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

Primary outcomes:
measure: 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 9 months, 11 days
measure: Median Time to Local Progression
timeFrame: 6-12 months
measure: 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment
timeFrame: 12 months
measure: Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis
timeFrame: One to three months of followup
measure: Pain at Sites of Metastases
timeFrame: One and three months of follow up
measure: Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy
timeFrame: Baseline and prior to termination of systemic therapy or protocol withdrawal
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: NCI - Radiation Oncology Branch; ROB
name: Deborah E. Citrin, MD
role: PRINCIPAL_INVESTIGATOR
References: