Small-cell Lung CancerPhase 3NCT04535739
PCI for Patients With ES-SCLC After RCT:a Prospective Randomized Study
A Phase 3 study testing prophylactic cranial irradiation in people with Small-cell Lung Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Small-cell Lung Cancer
- What is being tested?
- prophylactic cranial irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old,KPS≥70
- Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
- 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ；
- CR or PR after chemotherapy；
- no grade ≥II side effects;
- the estimated overall survival time ≥ 3 months;
- no serious medical disease or major organ dysfunction.
Who cannot join
- Patients with brain or nervous system metastases;
- Presence of high grade radiation comorbidities;
- Patients who are pregnant or lactating
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, master, 86 13801389769, zhouzongmei2013@163.com
About this study
Official title: A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.
Read the detailed description
Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.
- Conditions
- Small-cell Lung Cancer
- Being tested
- prophylactic cranial irradiation
- Keywords
- small cell lung cancer, Brain Metastases
- Medical subject headings
- Small Cell Lung Carcinoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic cranial irradiationRadiation
25Gy/2.5Gy/10f were given for PCI patients
| Study group | Role | What they receive |
|---|---|---|
| PCI group | Experimental | patients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy and prophylactic cranial irradiation。 Receives: Radiation: prophylactic cranial irradiation |
| control group | Other | patients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy。 Receives: Radiation: prophylactic cranial irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
rate of patients survival in 2 years
Measured: 2 year
Secondary outcomes (3)
progression-free survival
the rate of patients survival from the treatment to death or progress
Measured: 2 year
brain metastases rates
Cumulative incidence of brain metastases over 2 year
Measured: 2 year
side effect
HLVT
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Jul 2019
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jun 2022 (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
- 414 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535739
- Sponsor's protocol ID
- 17-184/1440
- Status last verified
- Oct 2019
- First submitted
- 28 Aug 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study for Prophylactic Cranial Irradiation After Chemotherapy and Thoracic Radiation Therapy in Patients With Extensive-stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04535739
- Acronym / sponsor ID
- 17-184/1440
- Conditions
- Small-cell Lung Cancer
- Keywords
- small cell lung cancer, Brain Metastases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 2 Sep 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.
prophylactic cranial irradiation （PCI）was verified to decrease the brain metastases rates and improve the overall survival（OS）for patients with limited stage small cell lung cancer.We hypothesis that patients with extensive-stage small cell lung cancer after chemotherapy and thoracic radiation can also benefit from PCI.
Detailed description
Patients with extensive-stage small cell lung cancer achieving CR or PR after chemotherapy and thoracic radiation therapy were randomly divided into observation group and prophylactic cranial irradiation (PCI) group to evaluate the effect of PCI on survival after radiation therapy for thoracic lesions. To preliminarily analyze the clinical characteristics of patients who would benefit from thoracic radiation therapy plus PCI. To explore the optimal treatment modality after chemotherapy + thoracic radiation therapy in patients with extensive-stage SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI group | Experimental | Radiation: prophylactic cranial irradiationpatients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy and prophylactic cranial irradiation。 |
| control group | Other | Radiation: prophylactic cranial irradiationpatients received 4-6 circles of chemotherapy of EP or EC，and patients with complete remission or partial remission (more than 1 site) after chemotherapy，patients received thoracic radiotherapy。 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-65 years old,KPS≥70
- Pathological or cytological diagnosis of stage IV small cell lung cancer (by using AJCC 7th edition staging criteria);
- 1-3 extra-cranial metastatic organs before chemotherapy; 4-6 cycles of CE or EP ；
- CR or PR after chemotherapy；
- no grade ≥II side effects;
Key exclusion criteria (3 listed)
- Patients with brain or nervous system metastases;
- Presence of high grade radiation comorbidities;
- Patients who are pregnant or lactating
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 |
|---|---|---|
| prophylactic cranial irradiation25Gy/2.5Gy/10f were given for PCI patients | Radiation | PCI group, control group |
Primary outcome
overall survival
Time frame: 2 year
rate of patients survival in 2 years
3 secondary outcomes
progression-free survival
Time frame: 2 year
brain metastases rates
Time frame: 2 year
side effect
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
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 prophylactic cranial irradiation 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 7 inclusion and 3 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 2 Sep 2020. 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, master (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?
overall 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 2 Sep 2020.