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Active, Not Recruiting

NCT Number: NCT01223248

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Melanoma Adnexal Diseases Bone CNS-Spinal CD/MEMBR, NOS Digestive System Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Outlet Obstruction Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Lymph Nodes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pyloric Stenosis Pyloric Stenosis, Hypertrophic Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Soft Tissue Stomach Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pisa, Pisa, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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."

Treatment and study plan

IGIMRT using a single dose of 24 Gy

Radiation

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.

IGIMRT 27 Gy in 3 fractions

Radiation

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.

Primary outcomes

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

    Time frame: 2 years

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

Secondary outcomes

  1. To compare toxicity outcomes

    Time frame: 2 years

  2. To compare patterns of failure between these two cohorts.

    Time frame: 2 years

  3. To look at changes in SUV uptake as a measure of tumor response.

    Time frame: 2 years

    For patients who are followed with PET/CTs

  4. changes in tumor perfusion

    Time frame: 2 years

    resulting from high-dose IGRT for patients treated with this approach to focal metastases using dynamic contrast-enhanced (DCE)-MRI.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • The Champalimaud Centre, Lisbon, Portugal
  • University of California, San Francisco
  • University of Pisa

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2010
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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