Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC (TRISS)

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

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.

Study Overview

• Status: Completed
• Conditions: Radiotherapy; Small Cell Lung Cancer Limited Stage
• Intervention / Treatment: Radiation: SIB; Radiation: Standard

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIB group; Patients in this group will receive concurrent twice-daily radiotherapy by SIB technique (95%PGTV 54Gy, 95%PTV 45Gy,both in 30 twice-daily fractions over 3 weeks, 5 days per week) and chemotherapy (etoposide and cisplatin).	Radiation: SIB; patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy; Other Names: chemotherapy with etoposide and cisplatin
Active Comparator: BID group; Patients in this group will receive concurrent twice-daily standard radiotherapy (95%PTV 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week, without SIB) and chemotherapy (etoposide and cisplatin).	Radiation: Standard; patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy; Other Names: chemotherapy with etoposide and cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	from the starting date of treatment until the date of death from any cause	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Progression Free Survival	from the starting date of treatment until the date of local disease progression	5 years
Metastasis Free Survival	from the staring date of treatment until the date of distant metastasis	5 years
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.
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.

Collaborators and Investigators

• Sponsor: Anhui Shi, MD
• Collaborators: Peking University First Hospital; Xijing Hospital; Peking University People's Hospital; Sun Yat-sen University; Fudan University; Peking Union Medical College Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking University Third Hospital; Henan Cancer Hospital; Jilin Provincial Tumor Hospital; Beijing Chao Yang Hospital; Beijing Hospital; China-Japan Friendship Hospital; First Affiliated Hospital of Xinjiang Medical University; Air Force General Hospital of the PLA
• Investigators: Principal Investigator: Anhui Shi, Doctor, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2017
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 10, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: small cell lung cancer limited stage; twice-daily radiotherapy; simultaneous integrated boosting technique
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Etoposide phosphate; Cisplatin
• Other Study ID Numbers: 2017YJZ19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No