Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy

Status:	Active, not recruiting
Conditions:	Skin Cancer, Ovarian Cancer, Cancer, Cancer, Skin and Soft Tissue Infections, Lymphoma, Orthopedic, Endocrine
Therapuetic Areas:	Dermatology / Plastic Surgery, Endocrinology, Oncology, Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - Any
Updated:	6/7/2018
Start Date:	October 2010
End Date:	October 2019

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

The purpose of this study is to find out which way of giving high-dose radiation works best
for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This
study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days)
or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy
(IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the
exposure to normal tissue. Currently there are no studies that compare the effects of giving
radiation in either hypofractionated doses (higher total doses of radiation spread out over
several treatment days) or a single-fraction dose (entire radiation dose given in one
treatment session).

The patient may be asked to participate in an additional part of this study where we will get
a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the
patient is asked to take part in this portion of the study, all they will need to do is get
up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result
of the treatment there are changes in the blood flow going to the cancer which could suggest
that the treatment may be successful.

In addition some patients can present new lesions and may be asked if they would like to have
these new lesions treated on the protocol. If they are given this option, this will not
extend their follow up period. The follow up of the new lesions will match with the prior
follow up dates.

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
non-measurable.

- 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 less than 2 mm from 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."

We found this trial at

sites

University of California at San Francisco

San Francisco, California 94143

Principal Investigator: Igor J. Barani, MD

from

San Francisco, CA