Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy
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 : 3 dose levels.
3-6 patients will be included at each dose level.3-18 patients will be included in the study.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I Study of Continuous Dosing of Sunitinib in Non GIST Sarcomas With Concomitant Radiotherapy|
- the number of DLT occurring at each dose level of sunitinib within 14 weeks after the start of treatment [ Time Frame: within 14 weeks after the start of treatment ]
- the number of early toxicities (within 14 weeks after the beginning of treatment) and late toxicities (after 14 weeks and until 12 months after the start of treatment) using NCI-CTC v3.0 and RTOG-EORTC [ Time Frame: within 12 months after the start of treatment ]
- response rate at 6 months using MRI (magnetic resonance imaging) [ Time Frame: 6 months after the start of treatment ]
- progression free survival measured from the date of inclusion to the date of first evidence of progression or date of death of any cause, or to the date of last follow up [ Time Frame: within 12 months after the start of treatment ]
- evolution of neo-angiogenesis during treatment measured by DCE-US [ Time Frame: within 6 weeks after the start of treatment ]
- correlation between clinical response and change of tumor perfusion measured by DCE-US [ Time Frame: within 12 months after the start of treatment ]
- proportion of patients operable after treatment [ Time Frame: at week 6 after the start of treatment ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||May 2017|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
|Experimental: association sunitinib radiotherapy||
All patients will be treated with sunitinib (3 dose level) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib.
Dose level 1 : 12.5 mg once daily Dose level 2 : 25 mg once daily Dose level 3 : 50 mg once daily. Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring.
Study design : 3 dose levels
Step 1 : 25 mg once daily Step 2 : 37.5 mg once daily Step 3 : 50 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308034
|Centre Oscar Lambret|
|Centre Léon Bérard|
|Lyon, France, 69373|
|CHU La Timone|
|Institut de Cancérologie de l'ouest|
|Saint Herblain, France|
|Institut Gustave Roussy|
|Principal Investigator:||Jean Yves Blay, PR||Centre Léon Bérard, Lyon|
|Principal Investigator:||Marie Pierre Sunyach||Centre Léon Bérard, Lyon|