NCT01761929

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2013

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed
Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

9.9 years

First QC Date

February 27, 2012

Last Update Submit

March 4, 2026

Conditions

Solid Tumors With Oligometastatic Spread

Keywords

oligometastaticoligometastasesstereotactic body radiotherapyradiation therapyOligometastasisStereotactic ablative bodyradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with lack of progressive disease for the index site at 1 year

    CT will be used for evaluation of the status of the local disease at the index site.

    10 years

Secondary Outcomes (7)

  • Number of index lesion(s) with lack of progressive disease at 1 year.

    10 years

  • Acute toxicity within 90 days of first fraction of radiotherapy

    10 years

  • Time to local progression for the index site(s)

    10 years

  • Time to distant disease progression (beyond known sites of oligometastases at time of study entry)

    10 years

  • Late toxicity occuring beyond 90 days related to SBRT.

    10 year

  • +2 more secondary outcomes

Other Outcomes (2)

  • Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval

    10 years

  • Explore pre-treatment prognostic factors derived from clinical data and correlative studies for local control of index site(s) at 1 year

    10 years

Study Arms (1)

Stereotactic Body Radiation Therapy

EXPERIMENTAL

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

Interventions

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 toleranceRADIATION

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.

Stereotactic Body Radiation Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

MAX protein, human

Study Officials

  • Rebecca K.S. Wong, MB ChB

    University Health Network - Princess Margaret Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

January 7, 2013

Study Start

March 7, 2013

Primary Completion

February 8, 2023

Study Completion

February 8, 2023

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

CA(1)