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5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases

This study is currently recruiting participants.
Verified September 2017 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761929
First Posted: January 7, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
  Purpose

This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.

The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.


Condition Intervention Phase
Solid Tumors With Oligometastatic Spread Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Proportion of patients with lack of progressive disease for the index site at 1 year [ Time Frame: 10 years ]
    CT will be used for evaluation of the status of the local disease at the index site.


Secondary Outcome Measures:
  • Number of index lesion(s) with lack of progressive disease at 1 year. [ Time Frame: 10 years ]
    The Modified Response Evaluation Criteria for solid Tumors (RECIST) will be used. By measuring the longest diameter (LD) of the lesions, response of individual lesions and overall response will be documented.

  • Acute toxicity within 90 days of first fraction of radiotherapy [ Time Frame: 10 years ]
    Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0

  • Time to local progression for the index site(s) [ Time Frame: 10 years ]
  • Time to distant disease progression (beyond known sites of oligometastases at time of study entry) [ Time Frame: 10 years ]
  • Late toxicity occuring beyond 90 days related to SBRT. [ Time Frame: 10 year ]
    Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.

  • Describe symptom profile [ Time Frame: 10 Years ]
  • Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities [ Time Frame: 10 years ]

Other Outcome Measures:
  • Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval [ Time Frame: 10 years ]
  • Explore pre-treatment prognostic factors derived from clinical data and correlative studies for local control of index site(s) at 1 year [ Time Frame: 10 years ]

Estimated Enrollment: 170
Study Start Date: March 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radiation Therapy
All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance
All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.

Detailed Description:
Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
  • Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
  • Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
  • Oligometastatic disease, maximum of 5 lesions.
  • At least one lesion is suitable for stereotactic body radiotherapy
  • All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months
  • ECOG ≤ 2
  • At least 18 yrs old

Exclusion Criteria:

  • Previous radiotherapy to the intended treatment site
  • Patient cannot tolerate physical set up required for SBRT
  • Active bowel obstruction, if treating abdominal/pelvic site
  • Chemotherapy within 2 weeks of intended radiation therapy
  • Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761929


Contacts
Contact: Rebecca K.S. Wong, MB ChB 416-946-4501 ext 2126 Rebecca.wong@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Rebecca K.S. Wong, MB ChB    416 946 4501 ext 2126    Rebecca.Wong@rmp.uhn.on.ca   
Principal Investigator: Rebecca Wong, MD         
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Rebecca K.S. Wong, MB ChB University Health Network - Princess Margaret Cancer Center
  More Information

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01761929     History of Changes
Other Study ID Numbers: UHN REB '11-0886-C'
First Submitted: February 27, 2012
First Posted: January 7, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

Keywords provided by University Health Network, Toronto:
oligometastatic
oligometastases
stereotactic body radiotherapy
radiation therapy
Oligometastasis
Stereotactic ablative body
radiotherapy