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
18 Years
N/A
Both
Solid Tumors With Oligometastatic Spread
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients with lack of progressive disease for the index site at 1 year
Outcome Description:
CT will be used for evaluation of the status of the local disease at the index site.
Outcome Time Frame:
10 years
Safety Issue:
No
Principal Investigator
Rebecca K.S. Wong, MB ChB
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network - Princess Margaret Cancer Center
Authority:
Canada: Ethics Review Committee
Study ID:
11-0886-C
NCT ID:
NCT01761929
Start Date:
March 2013
Completion Date:
March 2022
Related Keywords:
- Solid Tumors With Oligometastatic Spread
- oligometastatic
- oligometastases
- stereotactic body radiotherapy
- radiation therapy
- Oligometastasis
- Stereotactic ablative body
- radiotherapy
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