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Completed

NCT Number: NCT01761929

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

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.

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Key information

Conditions

Solid Tumors With Oligometastatic Spread

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network, Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Radiation

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

  3. Time to local progression for the index site(s)

    Time frame: 10 years

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

    Time frame: 10 years

  5. 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.

  6. Describe symptom profile

    Time frame: 10 Years

  7. Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities

    Time frame: 10 years

Other outcomes

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

    Time frame: 10 years

  2. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study 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

Acronym: 5fr SBRT

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Jan 7, 2013
Registry last updated
Mar 6, 2026

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.