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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
University of Pisa
University of California, San Francisco
The Champalimaud Centre, Lisbon, Portugal
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01223248
First received: October 14, 2010
Last updated: August 4, 2014
Last verified: August 2014
  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:


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 2015
Estimated Primary Completion Date: October 2015 (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
Pts in both the hypofractionated & single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI & DCE-MRI pretreatment for both arms & 1 hour after their initial treatment for single fraction pts, & within one hour of their initial & final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule & MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, & approximately 24 hours [MCPG2.3]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.
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
Pts in both the hypofractionated & single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI & DCE-MRI pretreatment for both arms & within 1 hour after their initial treatment for single fraction pts, & within one hour of their initial & final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule & MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, & approximately 24 hours [MCPG2.3]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.

  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 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."
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 Suspended
Pisa, Italy
Portugal
The Champalimaud Centre Recruiting
Lisbon, Portugal
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
The Champalimaud Centre, Lisbon, Portugal
Investigators
Principal Investigator: Michael Zelefsky, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
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: August 4, 2014
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 September 14, 2014