Clinical trial NCT01761929: 5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Tumors With Oligometastatic Spread
Keywords: oligometastatic
oligometastases
stereotactic body radiotherapy
radiation therapy
Oligometastasis
Stereotactic ablative body
radiotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2013-01-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Proportion of patients with lack of progressive disease for the index site at 1 year
timeFrame: 10 years
Secondary outcomes:
measure: Number of index lesion(s) with lack of progressive disease at 1 year.
timeFrame: 10 years
measure: Acute toxicity within 90 days of first fraction of radiotherapy
timeFrame: 10 years
measure: Time to local progression for the index site(s)
timeFrame: 10 years
measure: Time to distant disease progression (beyond known sites of oligometastases at time of study entry)
timeFrame: 10 years
measure: Late toxicity occuring beyond 90 days related to SBRT.
timeFrame: 10 year
measure: Describe symptom profile
timeFrame: 10 Years
measure: Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities
timeFrame: 10 years
Other outcomes:
measure: Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval
timeFrame: 10 years
measure: Explore pre-treatment prognostic factors derived from clinical data and correlative studies for local control of index site(s) at 1 year
timeFrame: 10 years
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Cancer Center
state: Ontario
Study officials:
affiliation: University Health Network - Princess Margaret Cancer Center
name: Rebecca K.S. Wong, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: