Small-cell Lung CancerPhase 3NCT04500145
Simultaneous Integrated Boost vs. Routine IMRT in Limited-stage Small-cell Lung Cancer
A Phase 3 study testing SIB-IMRT and routine IMRT in people with Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited staged small cell lung cancer. Involved node radiation（INF） replaced elective node irradiation（ENI） as the more popular since several trails compared the two regimes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- SIB-IMRT and routine IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 20 Oct 2021
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years old,KPS≥80
- pathological small cell lung cancer
- staged as limited disease SCLC（contralateral hilar invasion not included）
- receive radiotherapy concurrent or sequential with chemotherapy，if induction chemotherapy，got PR or SD
- no other tumors
- No serious medical diseases and dysfunction of major organs
- understand this study，able to complete the treatment，accept the following up and sign the informed consent
- Contraception in women of childbearing age.
Who cannot join
- other malignant tumor（historically or simultaneously）curable non-melanoma skin cancer and cervical carcinoma in situ not included
- Uncontrolled heart disease or myocardial infarction within 6 months
- History of mental illness
- Pregnancy or Lactation
- uncontrolled diabetes、hypertension
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
zongmei zhou, professor, 86 13801389769, zhouzongmei2013@163.com
About this study
Official title: A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC
Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited staged small cell lung cancer. Involved node radiation（INF） replaced elective node irradiation（ENI） as the more popular since several trails compared the two regimes. simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the toxicities compared with routine IMRT in limited disease small-cell lung cancer.
Read the detailed description
All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same time. The investigators are carrying out this trial to compare the efficacy, safety, side effects, and type of failure of the two radiotherapy techniques, which will provide a new choice and reliable basis for the future dose-segmentation study of limited-stage small-cell lung cancer.
- Conditions
- Small-cell Lung Cancer
- Being tested
- SIB-IMRT, routine IMRT
- Keywords
- Limited-stage small-cell lung cancer, radiotherapy, simultaneous integrated boost
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB-IMRTRadiation
60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time
routine IMRTRadiation
patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| SIB-IMRT | Active comparator | patients received radiotherapy using IMRT or VMAT，60Gy is given to the field of tumor and metastatic lymph nodes and 50Gy given to CR lesion and high-risk area.concurrent or sequential with 4-6 circles of chemotherapy of EP. Receives: Radiation: SIB-IMRT |
| routine | Other | patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy Receives: Radiation: routine IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
progress-free survival
the rate of patients survival from the treatment to death or progress
Measured: 2 year
Secondary outcomes (3)
overall survival
rate of patients survival in 2 years
Measured: 2 year
local control rate
recurrence rate of local field in 2 years
Measured: 2 year
side-effects
the rate of radiation pneumatic、oesophagitis、haematological toxicity
Measured: 3-6months after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start20 Jul 2017
- Primary completion20 Jul 2021 (estimated)
- Study completion20 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zongmei Zhou, Chinese Academy of Medical Sciences
- Investigators
- zongmei zhou, PhD, Principal investigator, national cancer hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500145
- Sponsor's protocol ID
- CH-L-072
- Status last verified
- Jan 2021
- First submitted
- 3 Aug 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC
- ClinicalTrials.gov ID
- NCT04500145
- Acronym / sponsor ID
- CH-L-072
- Conditions
- Small-cell Lung Cancer
- Keywords
- Limited-stage small-cell lung cancer, radiotherapy, simultaneous integrated boost
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 20 Jul 2021 (estimated)
- Study completion
- 20 Oct 2021 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited staged small cell lung cancer. Involved node radiation（INF） replaced elective node irradiation（ENI） as the more popular since several trails compared the two regimes. simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the toxicities compared with routine IMRT in limited disease small-cell lung cancer.
Detailed description
All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same time. The investigators are carrying out this trial to compare the efficacy, safety, side effects, and type of failure of the two radiotherapy techniques, which will provide a new choice and reliable basis for the future dose-segmentation study of limited-stage small-cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIB-IMRT | Active comparator | Radiation: SIB-IMRTpatients received radiotherapy using IMRT or VMAT，60Gy is given to the field of tumor and metastatic lymph nodes and 50Gy given to CR lesion and high-risk area.concurrent or sequential with 4-6 circles of chemotherapy of EP. |
| routine | Other | Radiation: routine IMRTpatients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-70 years old,KPS≥80
- pathological small cell lung cancer
- staged as limited disease SCLC（contralateral hilar invasion not included）
- receive radiotherapy concurrent or sequential with chemotherapy，if induction chemotherapy，got PR or SD
- no other tumors
Key exclusion criteria (5 listed)
- other malignant tumor（historically or simultaneously）curable non-melanoma skin cancer and cervical carcinoma in situ not included
- Uncontrolled heart disease or myocardial infarction within 6 months
- History of mental illness
- Pregnancy or Lactation
- uncontrolled diabetes、hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIB-IMRT60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time | Radiation | SIB-IMRT |
| routine IMRTpatients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy | Radiation | routine |
Primary outcome
progress-free survival
Time frame: 2 year
the rate of patients survival from the treatment to death or progress
3 secondary outcomes
overall survival
Time frame: 2 year
local control rate
Time frame: 2 year
side-effects
Time frame: 3-6months after radiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zongmei zhou, PhD principal investigator
national cancer hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIB-IMRT and routine IMRT in people with Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zongmei zhou, Professor (86 13801389769, zhouzongmei2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progress-free survival (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2021.