Brain MetastasesPhase 3PCINCT00745797
Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy
A Phase 3 study testing Radiotherapy in people with Brain Metastases, run by Yi-Long Wu at 1 site in China.
Trial summary
1. Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI. 2. The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) . 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Aug 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
- No previous history of radiotherapy and surgery of brain
- Agree to radiotherapy
- age > 18 and <75 years
- ECOG performance status 1 or less
- Good renal and hepatic and haematological (absolute neutrophils count 15 x1O9/L and platelet count 90 x 109/L,HB>=80g /DL) functions
- Have provided informed consent
Who cannot join
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer
Trial locations and contacts
1 site in 1 country.
China1 site
Lung Cancer Research Institute & Cancer Center of Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
About this study
Official title: Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial
- Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
- The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
- The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).
Read the detailed description
- Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
- PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
- But its impact on overall and disease free survival is uncertain.
- Conditions
- Brain Metastases
- Being tested
- Radiotherapy
- Keywords
- nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Also called Radiotherapy,Dehydration drugs, elevated white blood drugs,
blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic WBRT | Experimental | Take the whole brain radiotherapy radiotherapy Receives: Radiation: Radiotherapy |
| Observer Group | No intervention | The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
Measured: 2.5years
Secondary outcomes (1)
1year survival,overall survival,incidence rate of radioactive brain injured
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: this trial enroll extremely slow and No funding support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi-Long Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi-Long Wu, Chinese Society of Lung Cancer
- Investigators
- WU YI LONG, MD, Principal investigator, Chinese Society of Lung Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745797
- Sponsor's protocol ID
- CSLC0801
- Acronym
- PCI
- Status last verified
- Mar 2017
- First submitted
- 2 Sep 2008
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Cranial Irradiation (PCI) Versus no PCI in Non Small Cell Lung Cancer After a Response to Chemotherapy：A Multi-center Randomized Phase ⅢTrial
- ClinicalTrials.gov ID
- NCT00745797
- Acronym / sponsor ID
- PCI / CSLC0801
- Conditions
- Brain Metastases
- Keywords
- nonsmall cell lung cancer, brain metastasis, prophylactic cranial irradiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: this trial enroll extremely slow and No funding support
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yi-Long WuUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Sep 2008 (estimated)
- 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.
- Patients with confirmed advanced NSCLC and any response to 3-6 cycles of chemotherapy, were randomized to receive PCI (30 Gy/10fr) or no PCI.
- The primary endpoint was the cumulative incidence of symptomatic brain metastases (BM) .
- The study was sized to detect a hazard ratio of 0.37 with 80% power and 2-sided 5% significance (60 events, 206 patients).
Detailed description
- Prophylactic cranial irradiation (PCI) significantly reduces the risk of brain metastases (BM) and improves survival in patients with extensive disease small cell lung cancer after a response to chemotherapy .
- PCI has also demonstrated to reduce or delay the incidence of CNS failure in non small cell lung cancer patients after primary therapy.
- But its impact on overall and disease free survival is uncertain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic WBRT | Experimental | Radiation: RadiotherapyTake the whole brain radiotherapy radiotherapy |
| Observer Group | No intervention | –The first 14 days after randomization and patient follow-up after 1 month to complete the FACT-L questionnaire and the MMSE scale. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients were required to have histologically or cytologically documented NSCLC and no brain metastasis documented by magnetic resonance imaging (MRI)within 21 days after confirmed response (RR+SD) to chemotherapy
- No previous history of radiotherapy and surgery of brain
- Agree to radiotherapy
- age > 18 and <75 years
- ECOG performance status 1 or less
Key exclusion criteria (3 listed)
- Seizure cannot be controled by the drugs
- Combined with other disease of the brain such as tumour or infarction
- Hypersensitivity to MR enhancer
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 |
|---|---|---|
| RadiotherapyAlso: Radiotherapy,Dehydration drugs, elevated white blood drugs,blood transfusions, platelet transfusions, antibiotics, antipyretic analgesics and anesthetics | Radiation | Prophylactic WBRT |
Primary outcome
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) .
Time frame: 2.5years
1 secondary outcome
1year survival,overall survival,incidence rate of radioactive brain injured
Time frame: 2 years
Results and safety
The study was stopped early (reason given: this trial enroll extremely slow and No funding support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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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.
WU YI LONG, MD principal investigator
Chinese Society of Lung Cancer
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 Radiotherapy in people with Brain Metastases, run by Yi-Long Wu 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: stopped early, as of the sponsor's last update on 6 Mar 2017. 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?
The study was stopped early (reason given: this trial enroll extremely slow and No funding support). Results are not available in the source record.
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?
The primary endpoint is the cumulative incidence of symptomatic brain metastases (BM) . (time frame: 2.5years). 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 6 Mar 2017.