Small Cell Lung CancerPhase 2NCT02605811
Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer
A Phase 2 study testing temozolomide and prophylaxis cranial radiotherapy in people with Small Cell Lung Cancer and Metastatic Carcinoma, run by Guangzhou Medical University at 1 site in China.
Trial summary
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer, Metastatic Carcinoma
- What is being tested?
- temozolomide and prophylaxis cranial radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Dec 2021
- Phase
- Phase 2
- 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
- Histological or cytological diagnosis of small-cll lung cancer histology
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- Local stage SCLC without distant metastases
- After 1st-line chemotherapy (EP or IP) at least 4 cycles
- After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
Show all 10Show fewer
- CR or PR assessment by RECIST(1.0) before randomized
- Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
- Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Who cannot join
- Mixed non-small cell lung cancer histology
- Neck and supraclavicular lymph node metastasis
- Be allergic to temozolomide or intolerable to radiotherapy
- Any unstable systemic disease
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Haihng Yang, MD contact
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Guangzhou MC
Guangzhou, Guangdong, 510120
Haihong Yang, Dr., 0862083062825, bjrf2009@yahoo.com
Haihong Yang, Dr.
About this study
Official title: Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.
Read the detailed description
We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.
- Conditions
- Small Cell Lung Cancer, Metastatic Carcinoma
- Being tested
- temozolomide, prophylaxis cranial radiotherapy
- Keywords
- limited small cell lung cancer, brain metastases, prophylactic cranial radiotherapy, temozolomide
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomideDrug
Also called Temozolomide Capsules
prophylaxis cranial radiotherapyRadiation
Also called PCI
2
| Study group | Role | What they receive |
|---|---|---|
| temozolomide | Experimental | temozolomide oral 150mg/m2 d1-5/28d for 12 cycles Receives: Drug: temozolomide |
| prophylaxis cranial radiotherapy | Active comparator | prophylaxis cranial radiotherapy,25-30Gy/10Fra Receives: Radiation: prophylaxis cranial radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year incidence of brain metastases
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 posted16 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
- Investigators
- Hailing Yang, MD, Principal investigator, the first affiliated hospital of Guangzhou MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605811
- Sponsor's protocol ID
- GACA1501
- Status last verified
- Mar 2019
- First submitted
- 12 Nov 2015
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02605811
- Acronym / sponsor ID
- GACA1501
- Conditions
- Small Cell Lung Cancer, Metastatic Carcinoma
- Keywords
- limited small cell lung cancer, brain metastases, prophylactic cranial radiotherapy, temozolomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Nov 2015 (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.
To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.
Detailed description
We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| temozolomide | Experimental | Drug: temozolomidetemozolomide oral 150mg/m2 d1-5/28d for 12 cycles |
| prophylaxis cranial radiotherapy | Active comparator | Radiation: prophylaxis cranial radiotherapyprophylaxis cranial radiotherapy,25-30Gy/10Fra |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histological or cytological diagnosis of small-cll lung cancer histology
- 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
- Local stage SCLC without distant metastases
- After 1st-line chemotherapy (EP or IP) at least 4 cycles
Key exclusion criteria (5 listed)
- Mixed non-small cell lung cancer histology
- Neck and supraclavicular lymph node metastasis
- Be allergic to temozolomide or intolerable to radiotherapy
- Any unstable systemic disease
- Pregnant or lactating women
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 |
|---|---|---|
| temozolomideAlso: Temozolomide Capsules | Drug | temozolomide |
| prophylaxis cranial radiotherapyAlso: PCI2 | Radiation | prophylaxis cranial radiotherapy |
Primary outcome
2-year incidence of brain metastases
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 28 Mar 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Haihng Yang, MD contact
Hailing Yang, MD principal investigator
the first affiliated hospital of Guangzhou MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing temozolomide and prophylaxis cranial radiotherapy in people with Small Cell Lung Cancer and Metastatic Carcinoma, run by Guangzhou Medical University 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 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 28 Mar 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Haihong Yang, MD (862083062825, bjrf2009@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year incidence of brain metastases (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 28 Mar 2019.