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

Metastatic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678158
• Other study ID #: 06-101
• Status: Completed
• Phase: Phase 1
• First received: May 13, 2008
• Last updated: November 16, 2015
• Start date: August 2006
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Disease
• Neoplasm Metastasis

Intervention

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 .

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	To obtain information on the effect of high-dose external beam irradiation on the biodistribution and pharmacokinetics of FLT.		2 years	No
Secondary	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	No

External Links

•   Memorial Sloan Kettering Cancer Center