Beijing Cancer Hospital
Beijing, China
NCT Number: NCT03214003
This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Beijing, China
Three hundred and twenty-six patients with a histological or cytological proven diagnosis of SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from May 2017 to May 2020.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy
Other names: chemotherapy with etoposide and cisplatin
patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy
Other names: chemotherapy with etoposide and cisplatin
Time frame: 5 years
from the starting date of treatment until the date of death from any cause
Time frame: 5 years
from the starting date of treatment until the date of local disease progression
Time frame: 5 years
from the staring date of treatment until the date of distant metastasis
Time frame: from baseline, immediately after radiotherapy and an average of 3 months up to 24 months. Then through study completion, an average of 6 months.From date of randomization until the date of death from any cause, assessed up to 120 months.
assessed from completed questionnaires. Assessments using Physicians Global Assessment to measure quality of life.
Time frame: from baseline, immediately after radiotherapy and an average of 1 week up to 12 weeks, an average of 3 months up to 24 months. Up to 120 weeks.
acute toxicity (defined as toxicity occurring between the start of treatment and up to 3 months after completion of treatment, and assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 5.0]), late toxicity (more than 3 months after completion of treatment, and assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 5.0])
Anhui Shi, MD
Other
Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study
Acronym: TRISS
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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