Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC

Radiotherapy Clinical Trial

— TRISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214003
• Other study ID #: 2017YJZ19
• Status: Completed
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: January 30, 2023

Study information

• Verified date: June 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: January 30, 2023
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Read the patient information and Sign the informed consent before enrollment

• Either sex, age =18 and =70

• Histologically or cytologically confirmed SLCL

• Limited stage disease(AJCC, 2009 version 7), stage I-III(T any, N any, M0) that can be safely treated with definitive radiation doses, excludes T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, clinical nonmalignant diagnosis by investigator when the pleural is too few to obtain cytological evidence.

• measurable lesion according RECIST 1.1

• PS ECOG 0-1

• having zero to two cycles of systemic chemotherapy with etoposide and cisplatin (cisplatin 60-80 mg/m2 at day1 or divided into two to three days, etoposide 100-120 mg/m2 at day 1 to 3, Q21d, and the treatment delay between two cycles shouldn't be more than 14days).

• patients especially female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception. Man must also use adequate contraception

• adequate haematological function: white blood cell =3.0×109/L , neutrophils =1.5×109/L, platelet =100×109/L, hemoglobin =90g/L.

• adequate liver and renal function: total bilirubin =1.5 ×upper limit normal , alanine transaminase and aspartate aminotransferase =1.5 ×upper limit normal, normal serum creatinine and/or calculated creatinine clearance =60ml/min.

Exclusion Criteria:

• prior surgical resection of the primary tumor or prior RT for lung cancer

• mixed small-cell and non-small-cell histological features

• contemporaneous immunotherapy or target therapy

• pregnancy or lactation

• physical or mental disease that could impact treatment plan

• unable to understand the trial, or could not follow the process

• to refuse the sign the informed consent.

• no history of previous malignancy in the past 5 years (except non-melanomatous skin or in situ servix carcinoma)

• be allergic to any known protocol in this trail

• be enrolled in other clinical trial in past 30days

Related Conditions & MeSH terms

• Lung Neoplasms
• Radiotherapy
• Small Cell Lung Cancer Limited Stage
• Small Cell Lung Carcinoma

Intervention

Radiation:
• SIB
patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy
• Standard
patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing

Sponsors (16)

Lead Sponsor

Collaborator

Anhui Shi, MD

Air Force General Hospital of the PLA, Beijing Chao Yang Hospital, Beijing Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital, First Affiliated Hospital of Xinjiang Medical University, Fudan University, Henan Cancer Hospital, Jilin Provincial Tumor Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Sun Yat-sen University, Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	from the starting date of treatment until the date of death from any cause	5 years
Secondary	Local Progression Free Survival	from the starting date of treatment until the date of local disease progression	5 years
Secondary	Metastasis Free Survival	from the staring date of treatment until the date of distant metastasis	5 years
Secondary	health related quality of life	assessed from completed questionnaires. Assessments using Physicians Global Assessment to measure quality of life.	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.
Secondary	acute and late toxicity	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])	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.