Entry Detail
| General information | |
| Database: | DB00491 |
| Objective: | The purpose of the STAR trial is to compare the standard treatment strategy (conventional continuation strategy, CCS) with a novel drug free interval strategy (DFIS) which includes planned treatment breaks. |
| Authors: | Collinson FJ, et al |
| Title: | The STAR trial protocol: a randomised multistagephase II/III study of Sunitinib comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the firstline treatment of locally advanced/metastatic renal cancer. |
| Journal: | BMC Cancer. |
| Year: | 2012 |
| PMID: | 23241439 |
| Trial Design | |
| Clinical Trial Id: | ISRCTN 06473203. |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | renal cell carcinoma |
| Cancer Subtype: | advanced clear cell renal carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a pragmatic UK, multicentre twoarm, randomised (I:I) controlled, multistage, openlabelphase II/III trial |
| Key Patients Feature: | patients with inoperable locally advanced ormetastatic clear cell renal cell cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:Sunitinib standard treatment strategy (conventional continuation strategy, CCS)B:drug free interval strategy (DFIS) |
| Treatment Info: | Participants will be randomised (1:1) to either a sunitinib CCS or a DFIS. |
| Primary End Point: | The overall aim of the trial is to determine whether a DFIS is noninferior, in terms of 2year overall survival (OS) and quality adjusted life years (QALY) (averaged over treatment and follow up), compared to a CCS. The QALY primary endpoint was selected to assess whether any detriment in terms of OS could be balanced with improvements in quality of life (QoL). |
| Secondary End Point: | NA |
| Patients Number: | 1000 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | na |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | NA |