Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone

Phase I Dose Escalation Study Using High-Dose Single Fraction Image-Guided Radiotherapy for Metastatic Lesions to Soft Tissue Masses, Lymph Node, or Bone

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Disease
• Intervention / Treatment: Radiation: intensity modulated radiation therapy

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Patients with metastatic disease to soft tissue.	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). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .
Experimental: 2; Patients with metastatic disease to lymph nodes.	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). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .
Experimental: 3; 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). Some of these patients have participated in the optional FLT-PET scan portion of the study. Some of these patients have under gone an optional MRI scan which take place within one hour of the radiation treatment .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the feasibility of single dose image-guided intensity modulated radiotherapy (IGIMRT)for metastatic disease to soft tissue, lymph nodes or bones.	conclusion of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	conclusion of the study
To obtain information on the effect of high-dose external beam irradiation on the biodistribution and pharmacokinetics of FLT.	2 years
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.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 13, 2008
• First Submitted That Met QC Criteria: May 14, 2008
• First Posted (Estimate): May 15, 2008

Study Record Updates

• Last Update Posted (Estimate): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Bone; Lymph Nodes; Soft Tissue; High Does Single Fraction IGRT
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 06-101