metastatic renal cell carcinoma
Conditions
Interventions
Group 1:SBRT for metastases & sunitinib
Group 2:sunitinib
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject is diagnosed with mRCC by imaging and cytoreductive nephrectomy; 2. The subject previously underwent radical nephrectomy / partial nephrectomy, and is clearly diagnosed with RCC according to pathology and identified with metastasis after surgery; 3. The mRCC patient has at least one metastasis, which meets RECIST 1.1 or MDA criteria for bone metastases. The metastases must meet the following criteria: (1) The diameter of metastasis is 1-6cm, and there are no more than 5 metastases; (2) In case of lung metastases alone, at least one metastasis of more than or equal to 3cm must be included; (3) The subject is more than or equal to 18 years old; 5. The subject has 0-2 points according to ECOG; 6. The life expectancy is more than or equal to 3 months; 7. Functions of major organs: No significant abnormalities are found in liver, kidney, bone marrow, heart and other important organs; 8. No significant abnormalities are found on ECG, or the abnormalities show no clinical significance; 9. Women of childbearing age must confirm non-pregnancy prior to enrollment. All enrolled subjects (male and female) must take adequate barrier methods for birth control during the entire treatment period and within 4 weeks after the end of treatment; 10. The subject must be capable of understanding and voluntarily signing the informed consent. The informed consent must be signed prior to any tests.
Exclusion criteria
Exclusion criteria: The physicians determine that the patient cannot safely receive the clinical treatment due to any other severe diseases or clinical conditions, including but not limited to the following items: 1. Contraindications for radiotherapy; 2. Primary renal lesions which cannot be surgically removed; 3. Metastasis with the diameter of more than 6cm; 4. More than 5 measurable metastases; 5. Accompanied by liver and brain metastases; 6. Previously received radiotherapy for mRCC; 7. Previously received systemic treatment for mRCC (targeted drug therapy/immunotherapy/cytokine therapy) except sunitinib; 8. The mRCC patient currently receives sunitinib as first-line treatment, and the disease progression has occurred (RECIST-1.1 and MDA criteria for bone metastases); 9. Severe heart and cerebral vascular diseases, uncontrollable hypertension and diabetes, and incomplete renal function or renal failure; 10. HIV positive, or other immune deficiencies; 11. Clear history of metal illness, affecting his/her understanding of informed consent and compliance with study; 12. Other malignant tumors which have not been cured; 13. Women in pregnancy or lactation; 14. Any condition that is not stable or may jeopardize the safety of the subject and his/her compliance with the study; or other factors that the investigators believe that the subject is not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free surviva;Quality of life;Disease control rate;1-year local control rate; | — |
Countries
China
Contacts
Public ContactDong Pei
Sun Yat-sen University Cancer Center
Outcome results
None listed