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

October 14, 2010
August 4, 2014
October 2010
October 2015   (final data collection date for primary outcome measure)
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
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 limited metastatic disease
Complete list of historical versions of study NCT01223248 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Ovarian Cancer
  • Sarcoma
  • Bone
  • CNS-Spinal CD/MEMBR, NOS
  • Lymph Nodes
  • Soft Tissue
  • 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.
  • 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.
  • 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
    Intervention: Radiation: IGIMRT using a single dose of 24 Gy
  • 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
    Intervention: Radiation: IGIMRT 27 Gy in 3 fractions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
October 2015
October 2015   (final data collection date for primary outcome measure)

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."
Both
18 Years and older
No
Contact: Michael Zelefsky, MD 212-639-6802
Contact: Yoshiya Yamada, MD 212-639-2950
United States,   Italy,   Portugal
 
NCT01223248
10-154
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • University of Pisa
  • University of California, San Francisco
  • The Champalimaud Centre, Lisbon, Portugal
Principal Investigator: Michael Zelefsky, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP