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A Phase III Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients With Metastatic Cancer

Phase 3
18 Years
Open (Enrolling)
Melanoma, Ovarian Cancer, Sarcoma, Bone, CNS-Spinal CD/MEMBR, NOS, Lymph Nodes, Soft Tissue

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Trial Information

A Phase III Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients With Metastatic Cancer

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of cancer (including epithelial
carcinoma, sarcoma, and melanoma) The diagnosis can be done at MSKCC or at
participating institutions.

- Sites of metastatic disease to be treated on protocol are limited to bone, spine,
soft tissue, and lymph nodes only.

- Patients with American Joint Committee on Cancer (6th edition, 2002) Stage IV cancer
with distant metastases

- Age 18 years or older

- Life expectancy >3 months

- Maximum tumor dimension of ≤6 cm in lymph nodes, soft tissue, osseous metastases, or
spinal metastases seen on imaging (computed tomography [CT], magnetic resonance
imaging [MRI], or PET/CT) and considered amenable for RT.

- If the lesion(s) to be treated are soft-tissue or lymph Nodes unidimensionally
measurable disease is required. Bone & spine lesions are eligible even if considered

- Measurable disease is defined as:

- ≥ 10mm for soft-tissue lesions

- ≥ 15mm on the short axis of lymph nodes

- KPS ≥ 80

- Patients must have normal bone marrow function as defined below:(within 2 months of
registration) Hemoglobin ≥9.0 g/dl Absolute neutrophil count (ANC) ≥1,500/μl
Platelets ≥100,000/μl

Exclusion Criteria:

- Prior radiotherapy delivered to the target region

- Disease to be treated on protocol is within 2 mm of the spinal cord and therefore
will not meet dose constraints*

- Pregnancy or Breast-Feeding (Participants of child-bearing potential are eligible but
must consent to using effective contraception during therapy and for at least 3
months after completing therapy).

- Chemotherapy given on the day of the planned radiotherapy treatment

- Lesions which comprise >70% of the width of weight bearing bones, such as the femur.

- Existing cortical bone destruction, where orthopedic stabilization would be required.

- Areas to be treated on protocol do not include metastases to liver, brain or lung.

- Note: Patients with eligible and ineligible lesions will be accrued to this
protocol. Only target eligible lesions will be treated per protocol. Other
eligible and ineligible lesions will be treated at the discretion of the
treating physician."

Type of Study:


Study Design:

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

Outcome Measure:

To compare the loco-regional control rates of two established hypo-fractionated radiation treatment regimens

Outcome Description:

a single dose of 24 Gy versus 27 Gy in three fractions for patients with metastatic disease

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Michael Zelefsky, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2010

Completion Date:

October 2013

Related Keywords:

  • Melanoma
  • Ovarian Cancer
  • Sarcoma
  • BONE
  • CNS-Spinal CD/MEMBR, NOS
  • Lymph Nodes
  • radiation
  • Hypofractionated Image- Guided
  • RT
  • 10-154
  • Melanoma
  • Ovarian Neoplasms
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of California San Francisco San Francisco, California  941104206