Clinical trial NCT00678158: Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Disease
Keywords: High Does Single Fraction IGRT
Bone
Lymph Nodes
Soft Tissue
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-05-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 20 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.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven cancer verified at MSKCC
* Imaging evidence of lymph node metastases, bone metastases or soft tissue disease
* Age \> or = to 18 years
* KPS \> or = to 80
* Epidural disease is acceptable as long as the dose to the spinal cord ≤ 14 Gy
* Able to tolerate immobilization cradle positioning

Exclusion Criteria:

* Target lesion not visible on conventional CT scan
* Unable to be administered intravenous CT contrast safely
* Prior radiation to the planned target region. A second metastatic lesion would not be eligible if the area received or will receive any dose (5% or greater isodose line)from a prior or planned single fraction treatment
* Patients receiving concurrent chemotherapy (within 1 week of RT)
* Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to 15-16 Gy dose constraints
* Weight-bearing bones with significant cortical destruction from tumor. In these cases, patients will be referred for orthopedic consultation for rod stabilization procedures.
* Subjects with more than 4 metastases to bone
* Any metastatic lesion larger than 8 cm in its greatest diameter

Primary outcomes:
measure: To assess the feasibility of single dose image-guided intensity modulated radiotherapy (IGIMRT)for metastatic disease to soft tissue, lymph nodes or bones.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To establish the maximal safe single fraction dose for osseous and soft tissue metastatic lesions using IG-IMRT in a Phase I dose escalation study.
timeFrame: conclusion of the study
measure: To obtain information on the effect of high-dose external beam irradiation on the biodistribution and pharmacokinetics of FLT.
timeFrame: 2 years
measure: To obtain preliminary information on the changes in tumor perfusion resulting from high-dose, single fraction IGRT for patients treated with approach to focal metastases using dynamic contrast-enhanced (DCE)-MRI.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Zelefsky, MD
role: PRINCIPAL_INVESTIGATOR
References: