Conformal Radiation Therapy in Treating Patients With Metastatic Cancer Outside the Brain
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|ClinicalTrials.gov Identifier: NCT00550654|
Recruitment Status : Terminated (Study was terminated due to poor accrual.)
First Posted : October 30, 2007
Results First Posted : September 18, 2012
Last Update Posted : January 13, 2017
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 or disease||Intervention/treatment||Phase|
|Kidney Cancer Melanoma (Skin) Metastatic Cancer Ovarian Cancer Sarcoma 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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Hypofractionated Highly Conformal Radiation With Helical Tomotherapy for Extra-Cranial Oligo|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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 InventoryRadiation: 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.
- 6-month Local Control (i.e., Complete Response, Partial Response, or Stable Disease) at All Treated Sites of Metastatic Disease [ Time Frame: 6 months ]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.
- Number of Participants With Adverse Events [ Time Frame: 9 months, 11 days ]Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
- Median Time to Local Progression [ Time Frame: 6-12 months ]Interval from initiation of treatment on protocol to symptomatic or radiographic progression.
- 12 Month Local Control in All Sites of Treatment, and at Each Site of Treatment [ Time Frame: 12 months ]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.
- Interfraction and Intrafraction Motion With Megavoltage Computed Tomography (CT) Based on Sites of Metastasis [ Time Frame: One to three months of followup ]Megavoltage localization scans will be obtained and the physician and therapist will evaluate the cone beam image and compare this image to the expected image based on the patient's initial planning CT scan.
- Pain at Sites of Metastases [ Time Frame: One and three months of follow up ]Improvement in pain from baseline will be assessed by the Brief Inventory for Pain criteria.
- Tumor Doubling Times During Systemic Treatment Compared Between Tumors Untreated With Radiation (Newly Developed Tumors) and Tumors Which Have Received Radiation Therapy [ Time Frame: Baseline and prior to termination of systemic therapy or protocol withdrawal ]Rate of growth of the composite (total) treated volume (up to four sites) compared to the composite volume of up to four newly identified and untreated prospectively-identified (at the time of systemic progression) metastatic sites. Volume doubling time will be calculated assuming an exponential growth pattern.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550654
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Deborah E. Citrin, MD||NCI - Radiation Oncology Branch; ROB|