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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 2, 2014
Last verified: June 2014
  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: 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

Resource links provided by NLM:


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 [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    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 ] [ 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 ]
  • Late toxicity occuring beyond 90 days related to SBRT. [ Time Frame: 10 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • 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 ] [ 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: 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

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 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
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: 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

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: June 2, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 23, 2014