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Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction SBRT Regimen, for Extra-Cranial Oligometastases

This study is not yet open for participant recruitment.
Verified January 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01761929
First received: February 27, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  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
Extra-Cranial Oligometastases
 Radiation: SBRT
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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, and late toxicity occuring beyond 90 days related to SBRT. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Acute toxicity will be graded according to the Common Toxicity Criteria, v3.0, and late toxicity evaluated according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.

  • Time to local progression for the index site(s) [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Time to distant disease progression (beyond known sites of oligometastases at time of study entry) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

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: SBRT Radiation: SBRT
5 Fractions SBRT (daily) Max 40Gy (8Gy/fraction) at isocentre, 90% Planning Target Volume (PTV) coverage, max 130% within Gross Tumour Volume (GTV)

Detailed Description:

This is a prospective Phase II study. The purpose of this study is to examine the safety and efficacy of tumor control effect of a 5-fraction stereotactic body radiotherapy (SBRT) regimen for any metastatic location. 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 metastastic sites is required.
  • Radiological diagnosis of oligometastastic metastastic 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
  • Age > 18 yrs

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761929

Contacts
Contact: Rebecca Wong, MD 416-946-4501 ext 2126

Locations
Canada, Ontario
University Health Toronto Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Rebecca Wong, MD            
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Rebecca Wong, MD University Health Network - Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01761929     History of Changes
Other Study ID Numbers: 11-0886-C
Study First Received: February 27, 2012
Last Updated: January 3, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
SBRT
oligomets
oligometastases
stereotactic body radiation therapy
extra-cranial

ClinicalTrials.gov processed this record on May 16, 2013