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

Primary Purpose

Small Cell Lung Cancer Limited Stage, Radiotherapy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SIB
Standard
Sponsored by
Anhui Shi, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer Limited Stage focused on measuring small cell lung cancer limited stage, twice-daily radiotherapy, simultaneous integrated boosting technique

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SIB group

BID group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Overall survival
from the starting date of treatment until the date of death from any cause

Secondary Outcome Measures

Local Progression Free Survival
from the starting date of treatment until the date of local disease progression
Metastasis Free Survival
from the staring date of treatment until the date of distant metastasis
health related quality of life
assessed from completed questionnaires. Assessments using Physicians Global Assessment to measure quality of life.
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])

Full Information

First Posted
July 5, 2017
Last Updated
June 19, 2023
Sponsor
Anhui Shi, MD
Collaborators
Sun Yat-sen University, Fudan University, Xijing Hospital, Henan Cancer Hospital, Jilin Provincial Tumor Hospital, First Affiliated Hospital of Xinjiang Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Air Force General Hospital of the PLA, China-Japan Friendship Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, Beijing Hospital, Beijing Chao Yang Hospital, Peking University People's Hospital, Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03214003
Brief Title
Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anhui Shi, MD
Collaborators
Sun Yat-sen University, Fudan University, Xijing Hospital, Henan Cancer Hospital, Jilin Provincial Tumor Hospital, First Affiliated Hospital of Xinjiang Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Air Force General Hospital of the PLA, China-Japan Friendship Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, Beijing Hospital, Beijing Chao Yang Hospital, Peking University People's Hospital, Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer Limited Stage, Radiotherapy
Keywords
small cell lung cancer limited stage, twice-daily radiotherapy, simultaneous integrated boosting technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIB group
Arm Type
Experimental
Arm Description
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).
Arm Title
BID group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
SIB
Other Intervention Name(s)
chemotherapy with etoposide and cisplatin
Intervention Description
patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Standard
Other Intervention Name(s)
chemotherapy with etoposide and cisplatin
Intervention Description
patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy
Primary Outcome Measure Information:
Title
Overall survival
Description
from the starting date of treatment until the date of death from any cause
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Local Progression Free Survival
Description
from the starting date of treatment until the date of local disease progression
Time Frame
5 years
Title
Metastasis Free Survival
Description
from the staring date of treatment until the date of distant metastasis
Time Frame
5 years
Title
health related quality of life
Description
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 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.
Title
acute and late toxicity
Description
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])
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anhui Shi, Doctor
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

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

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