SBRT
Radiation3 sessions at least, up to 6. Neither specifc device is imposed.
NCT Number: NCT03408665
Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Centre Oscar Lambret, Lille, Nord, France
Patients will first go through an inclusion check-up consisting of:
Before the beginning of the treatment, a pre-therapeutic check-up is done:
The SBRT treatment is done in 3 to 6 times and no specific SBRT techniques are asked for, the investigator can choose according to the center habits.
After the treatment, a follow-up will be realized at 3, 6, 9, 12, 18, 24, 30 and 36 months and then once a year until the last patient included reach their 36th month of follow-up. The follow-up check-up consists of a clinical exam, biological test, tumor assessment and tolerance assessment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 sessions at least, up to 6. Neither specifc device is imposed.
Time frame: From baseline to 36 months following up.
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
Time frame: From baseline to 36 months following up.
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
Time frame: From baseline to 36 months following up.
Description of SBRT techniques used.
Time frame: From baseline to 36 months following up.
Description of reasons leading to SBRT scheme modification or interruption.
Time frame: From baseline to 36 months following up.
Overall survivall thanks to Kaplan-meier method, from registration date to date of death.
Time frame: From baseline to 36 months following up.
Progression-free survival (PFS) thanks to Kaplan-Meier method from registration date to date of progressive disease.
Time frame: From baseline to 36 months following up.
Description of toxicity associated to SBRT or the fiducial use thanks to NCI-CTCAE v4.0.
Time frame: From baseline to 36 months following up.
Q-TWIST consists in 3 clinical states: time in toxicity before progressive disease, time in progressive disease, time without toxicity nor progressive disease.
Time frame: From baseline to 36 months following up.
during the treatment and until 3 months after and the cumulative duration of the hospitalization over those 3 months.
Time frame: From baseline to 36 months following up.
Estimation of impact of SBRT technique used on SBRT efficacy according to L-PFS.
Time frame: From baseline to 36 months following up.
Estimation of impact of SBRT technique used on SBRT efficacy according to PFS.
Time frame: From baseline to 36 months following up.
Estimation of impact of SBRT technique used on SBRT efficacy according to OS.
Time frame: From Baseline to the 6-months follow-up
QLQ-C30 will be filled at baseline, at the 3-months follow-up and at the 6-months follow-up.
Centre Oscar Lambret
Other
Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
Acronym: STEREOLIVER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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