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Small Cell Lung Cancer Limited StageTRISSNCT03214003

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

A study testing SIB and Standard in people with Small Cell Lung Cancer Limited Stage and Radiotherapy, run by Anhui Shi, MD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SIB and Standard
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
1 siteChina
Study dates
30 Jun 2017to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

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

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.

Read the 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.

Being tested
SIB, Standard
Keywords
small cell lung cancer limited stage, twice-daily radiotherapy, simultaneous integrated boosting technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIBRadiation

    Also called chemotherapy with etoposide and cisplatin

    patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy

  • StandardRadiation

    Also called chemotherapy with etoposide and cisplatin

    patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy

Study groups in NCT03214003
Study groupRoleWhat they receive
SIB groupExperimentalPatients 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).
Receives: Radiation: SIB
BID groupActive comparatorPatients 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).
Receives: Radiation: Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: 5 years

Secondary outcomes (4)

  1. Local Progression Free Survival

    from the starting date of treatment until the date of local disease progression

    Measured: 5 years

  2. Metastasis Free Survival

    from the staring date of treatment until the date of distant metastasis

    Measured: 5 years

  3. health related quality of life

    assessed from completed questionnaires. Assessments using Physicians Global Assessment to measure quality of life.

    Measured: 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.

  4. 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])

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2017
  2. Study start30 Jun 2017
  3. Primary completion30 Apr 2021
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03214003
Sponsor's protocol ID
2017YJZ19
Acronym
TRISS
Status last verified
Jun 2023
First submitted
5 Jul 2017
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

Publications

  • Yu J, Jiang L, Zhao L, Yang X, Wang X, Yang D, Zhuo M, Chen H, Huang W, Zhu Z, Zhang M, Song Y, Li Q, Ma Z, Wang Q, Qu Y, Yu R, Yu H, Zhao J, Shi A; Trial Management Group. High-dose hyperfractionated simultaneous integrated boost radiotherapy versus standard-dose radiotherapy for limited-stage small-cell lung cancer in China: a multicentre, open-label, randomised, phase 3 trial. Lancet Respir Med. 2024 Oct;12(10):799-809. doi: 10.1016/S2213-2600(24)00189-9. Epub 2024 Aug 12.

    PubMed 39146944

Questions about this trial

What is this clinical trial studying?

A study testing SIB and Standard in people with Small Cell Lung Cancer Limited Stage and Radiotherapy, run by Anhui Shi, MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03214003, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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