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

Primary Purpose

Metastatic Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
intensity modulated radiation therapy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Disease focused on measuring High Does Single Fraction IGRT, Bone, Lymph Nodes, Soft Tissue

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Patients with metastatic disease to soft tissue.

Patients with metastatic disease to lymph nodes.

Patients with metastatic disease to the bone.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
To obtain information on the effect of high-dose external beam irradiation on the biodistribution and pharmacokinetics of FLT.
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.

Full Information

First Posted
May 13, 2008
Last Updated
November 16, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00678158
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Disease
Keywords
High Does Single Fraction IGRT, Bone, Lymph Nodes, Soft Tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients with metastatic disease to soft tissue.
Arm Title
2
Arm Type
Experimental
Arm Description
Patients with metastatic disease to lymph nodes.
Arm Title
3
Arm Type
Experimental
Arm Description
Patients with metastatic disease to the bone.
Intervention Type
Radiation
Intervention Name(s)
intensity modulated radiation therapy
Intervention Description
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 .
Primary Outcome Measure Information:
Title
To assess the feasibility of single dose image-guided intensity modulated radiotherapy (IGIMRT)for metastatic disease to soft tissue, lymph nodes or bones.
Time Frame
conclusion of the study
Secondary Outcome Measure Information:
Title
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.
Time Frame
conclusion of the study
Title
To obtain information on the effect of high-dose external beam irradiation on the biodistribution and pharmacokinetics of FLT.
Time Frame
2 years
Title
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zelefsky, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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