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

Purpose

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.

Condition	Intervention	Phase
Melanoma Ovarian Cancer Sarcoma Bone CNS-Spinal CD/MEMBR, NOS Lymph Nodes Soft Tissue	Radiation: IGIMRT using a single dose of 24 Gy Radiation: IGIMRT 27 Gy in 3 fractions	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients With Metastatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Ovarian Cancer Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To compare the loco-regional control rates of two established hypo-fractionated radiation treatment regimens [ Time Frame: 2 years ] [ Designated as safety issue: No ]
a single dose of 24 Gy versus 27 Gy in three fractions for patients with metastatic disease

Secondary Outcome Measures:

To compare toxicity outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To compare patterns of failure between these two cohorts. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To look at changes in SUV uptake as a measure of tumor response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
For patients who are followed with PET/CTs
changes in tumor perfusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
resulting from high-dose IGRT for patients treated with this approach to focal metastases using dynamic contrast-enhanced (DCE)-MRI.

Estimated Enrollment:	200
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: stereotactic IGIMRT using a single dose of 24 Gy This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease	Radiation: IGIMRT using a single dose of 24 Gy Patients in both the hypofractionated and single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. Twenty MSKCC patients (10 per treatment arm) will be accrued to undergo baseline DW-MRI and DCE-MRI pretreatment for both arms and 1 hour after their initial treatment for single fraction patients, and within one hour of their initial and final radiation treatment for the hypofractionated patients. Patients will be considered for this scan based on compliance to scan schedule and MRI availability for performing the scan within one hour of the planned IGRT. Forty MSKCC patients (20 per treatment arm) will be accrued for the blood collection (optional) 1-4 hours prior, 1 (+10 minutes) hour after, and approximately 24 hour [MCPG2.3]after treatment for single fraction patients.
Experimental: stereotactic IGIMRT 27 Gy in 3 fractions This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease	Radiation: IGIMRT 27 Gy in 3 fractions Patients in both the hypofractionated and single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. Twenty MSKCC patients (10 per treatment arm) will be accrued to undergo baseline DW-MRI and DCE-MRI pretreatment for both arms and within 1 hour after their initial treatment for single fraction patients, and within one hour of their initial and final radiation treatment for the hypofractionated patients. Patients will be considered for this scan based on compliance to scan schedule and MRI availability for performing the scan within one hour of the planned IGRT. Forty MSKCC patients (20 per treatment arm) will be accrued for the blood collection (optional) 1-4 hours prior, For patients undergoing hypofractionated treatment blood will be collected 1-4 hour prior, and 1 (+10 minutes) and approximately 24 hours [MCPG2.4]after radiation for the first and last fraction.

Arms

Assigned Interventions

Experimental: stereotactic IGIMRT using a single dose of 24 Gy

This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease

Radiation: IGIMRT using a single dose of 24 Gy

Patients in both the hypofractionated and single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. Twenty MSKCC patients (10 per treatment arm) will be accrued to undergo baseline DW-MRI and DCE-MRI pretreatment for both arms and 1 hour after their initial treatment for single fraction patients, and within one hour of their initial and final radiation treatment for the hypofractionated patients. Patients will be considered for this scan based on compliance to scan schedule and MRI availability for performing the scan within one hour of the planned IGRT. Forty MSKCC patients (20 per treatment arm) will be accrued for the blood collection (optional) 1-4 hours prior, 1 (+10 minutes) hour after, and approximately 24 hour [MCPG2.3]after treatment for single fraction patients.

Experimental: stereotactic IGIMRT 27 Gy in 3 fractions

This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease

Radiation: IGIMRT 27 Gy in 3 fractions

Patients in both the hypofractionated and single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. Twenty MSKCC patients (10 per treatment arm) will be accrued to undergo baseline DW-MRI and DCE-MRI pretreatment for both arms and within 1 hour after their initial treatment for single fraction patients, and within one hour of their initial and final radiation treatment for the hypofractionated patients. Patients will be considered for this scan based on compliance to scan schedule and MRI availability for performing the scan within one hour of the planned IGRT. Forty MSKCC patients (20 per treatment arm) will be accrued for the blood collection (optional) 1-4 hours prior, For patients undergoing hypofractionated treatment blood will be collected 1-4 hour prior, and 1 (+10 minutes) and approximately 24 hours [MCPG2.4]after radiation for the first and last fraction.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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."

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223248

Contacts

Contact: Michael Zelefsky, MD	212-639-6802
Contact: Yoshiya Yamada, MD	212-639-2950

Locations

United States, California
University of California San Francisco	Not yet recruiting
San Francisco, California, United States, 94143
Contact: Igor J. Barani, MD
Principal Investigator: Igor J. Barani, MD
United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Michael J. Zelefsky, M.D. 212-639-6802
Contact: Yoshiya Yamada, MD 212-639-2950
Principal Investigator: Michael J Zelefsky, M.D.
Italy
University of Pisa	Recruiting
Pisa, Italy
Contact: Carlo Greco, MD
Principal Investigator: Carlo Greco, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

University of Pisa

University of California, San Francisco

Investigators

Principal Investigator:

Michael Zelefsky, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01223248 History of Changes
Other Study ID Numbers:	10-154
Study First Received:	October 14, 2010
Last Updated:	April 10, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

radiation
Hypofractionated Image- Guided
IGIMRT
RT
10-154

Additional relevant MeSH terms:

Melanoma
Ovarian Neoplasms
Sarcoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on June 18, 2013