Solid Tumors With Oligometastatic Spread
Conditions
Keywords
oligometastatic, oligometastases, stereotactic body radiotherapy, radiation therapy, Oligometastasis, Stereotactic ablative body, radiotherapy
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.
Interventions
RADIATIONRadiation: 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.
Sponsors
University Health Network, Toronto
Princess Margaret Hospital, Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with lack of progressive disease for the index site at 1 year | 10 years | CT will be used for evaluation of the status of the local disease at the index site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of index lesion(s) with lack of progressive disease at 1 year. | 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. |
| Acute toxicity within 90 days of first fraction of radiotherapy | 10 years | Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0 |
| 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 | Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score. |
| Describe symptom profile | 10 Years | — |
| Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities | 10 years | — |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRebecca K.S. Wong, MB ChB
University Health Network - Princess Margaret Cancer Center
Outcome results
None listed