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


Phase 1
18 Years
85 Years
Open (Enrolling)
Both
Metastatic Disease

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

conclusion of the study

Safety Issue:

Yes

Principal Investigator

Michael Zelefsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-101

NCT ID:

NCT00678158

Start Date:

August 2006

Completion Date:

May 2013

Related Keywords:

  • Metastatic Disease
  • High Does Single Fraction IGRT
  • Bone
  • Lymph Nodes
  • Soft Tissue
  • Neoplasm Metastasis

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021