Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT01308034
Brief Summary:
The purpose of this study is to determine the safety of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST (gastro intestinal stromal tumor) sarcomas who cannot be treated by surgery.
The primary objective of the study is to determine the maximum tolerated dose (MTD) of continuous dosing of sunitinib in association with radiotherapy in patients with non GIST sarcomas who cannot be treated by surgery.
This study is a multicentre, open-label phase I with dose escalation : 2 dose levels.
3-6 patients will be included at each dose level.3-18 patients will be included in the study.
Detailed Description:
Study design : 2 dose levels
Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily
3-6 patients will be included at each of the sunitinib dose levels, depending on the number of DLTs (dose limiting toxicity) occurring in 14 weeks after start of treatment
DLT is defined as :
any grade 3 or 4 musculoskeletal or cutaneous toxicity within the field of radiation any other toxicity \> or = 4
Secondary objectives are :
* to evaluate the safety with late toxicities
* to estimate the response rate at 6 months
* to estimate the progression free survival
* to evaluate the proportion of patients with an operable tumour after treatment
Exploratory objectives are :
* to study evolution during treatment of neo-angiogenesis measured by dynamic contrast enhanced-ultrasonography (DCE-US)
* to study the correlation between clinical response and changes of tumor perfusion measured by DCE-US
Study:
NCT01308034
Study Brief:
Protocol Section:
NCT01308034