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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00678158 |
The purpose of this research study is to find out what IG-IMRT radiation dose works best for treatment of disease in bone or soft tissues. This protocol will study what dose level may work most effectively. The first part of study will treat 10 patients with 22 Gray. Gray (Gy) is the unit that is used to describe the dose of radiation that is being given to a person with cancer. After we confirm that 22 Gy is a safe and sufficient amount of radiation, we will then treat another group of patients with 24 Gy and so on until we reach 28 Gy. Each dose level starting with 24 Gy will enroll at least 10 patients per treatment site (bone, bowel and/or spine). Patients will be enrolled in each treatment category until 20 patients in each strata reach an evaluable time point of 3 months post-RT. When we understand what dose works best and has the least amount of bad effects, the study will then look to see how well the patients do after the radiation therapy. This study is trying to see how your doctor can best treat the cancer that has spread to the other parts of your body.
Condition | Intervention | Phase |
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Metastatic Disease |
Radiation: intensity modulated radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I Dose Escalation Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone |
Estimated Enrollment: | 290 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients with metastatic disease to soft tissue.
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Radiation: intensity modulated radiation therapy
Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy).
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2: Experimental
Patients with metastatic disease to lymph nodes.
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Radiation: intensity modulated radiation therapy
Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy).
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3: Experimental
Patients with metastatic disease to the bone.
|
Radiation: intensity modulated radiation therapy
Patients will be accrued at each dose level beginning at 22 Gy with increments of 2 Gy up to 28 Gy. Patients with a soft tissue mass, lymph nodes or focal bone metastases with lesions large enough to be imaged on CT scan will be accrued. Starting at 24 Gy, patients will be stratified in to 3 treatment categories: lesions involving bone, bowel, or spinal cord. Patients will be enrolled in each treatment category until 10 patients in that cohort reach an evaluable timepoint of 3 months post-RT. The maximum accrual is 20 for 22 Gy, and 90 (30 per treatment category) for each subsequent dose level (24-28 Gy).
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Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Zelefsky, MD | zelefskm@mskcc.org | |
Contact: Dale Lovelock, PhD | lovelocm@mskcc.org |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Michael Zelefsky, MD zelefskm@mskcc.org | |
Contact: Dale Lovelock, PhD lovelocm@mskcc.org | |
Principal Investigator: Michael Zelefsky, MD |
Principal Investigator: | Michael Zelefsky, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Michael Zelefsky, MD ) |
Study ID Numbers: | 06-101 |
Study First Received: | May 13, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00678158 History of Changes |
Health Authority: | United States: Institutional Review Board |
High Does Single Fraction IGRT Bone Lymph Nodes Soft Tissue |
Neoplasm Metastasis |
Neoplasms Neoplastic Processes Pathologic Processes Neoplasm Metastasis |