Extensive-stage Small Cell Lung CancerPhase 2/3NCT02772107
Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
A Phase 2/3 study testing Temozolomide, first-line chemotherapy and Prophylactic cranial irradiation in people with Extensive-stage Small Cell Lung Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive-stage Small Cell Lung Cancer
- What is being tested?
- Temozolomide, first-line chemotherapy and Prophylactic cranial irradiation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Jan 2018
- Phase
- Phase 2/3
- 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
- Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
- Patients must have measurable disease, this can include brain metastases
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) >1,500/µL; platelets >100,000/µL; hemoglobin >=9.0 g/dL
- Normal organ function, defined as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 × the upper limit of normal (ULN), or AST and ALT <=5 × the ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin <=1.5 × the ULN; serum creatinine <=1.5 × the ULN
- the time interval from the data of the last chemotherapy to random must be between 3 and 7 weeks
- Women of childbearing potential and men with partners of childbearing potential must agree to use a form of birth control that is acceptable to their physician to prevent pregnancy during treatment
- Patients must be informed of the investigational nature of this study and sign an informed consent form
Who cannot join
- Patients who are pregnant or breastfeeding
- Patients receiving other investigational agents
- Patients with leptomeningeal involvement
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
haitao tao, PhD, +861066937875, whatyouknow@126.com
About this study
Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC.
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Being tested
- Temozolomide, first-line chemotherapy, Prophylactic cranial irradiation, thoracic radiotherapy
- Keywords
- Small Cell Lung Carcinoma
- 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.
TemozolomideDrug
Temozolomide is a nonclassic oral alkylating agent. Temozolomide will be given alone as maintenance therapy in patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
first-line chemotherapyDrug
first-line chemotherapy must be platinum-based: cisplatin(75mg/m2 for d1) or carboplatin（AUC 5 for d1) combined with etoposide（100mg/m2 for d1-d3）
Prophylactic cranial irradiationRadiation
Prophylactic cranial irradiation was allowed if necessary
thoracic radiotherapyRadiation
thoracic radiotherapy was allowed if necessary
| Study group | Role | What they receive |
|---|---|---|
| BSC group | Experimental | Patients in the study will receive the following for the duration of the study:First-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cycles of therapy for the first-line chemotherapy. Radiotherapy was allowed. Follow-up until disease progression. Receives: Drug: first-line chemotherapy; Radiation: Prophylactic cranial irradiation; Radiation: thoracic radiotherapy |
| TMZ group | Experimental | Patients will receive platinum-based first-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cyclesfor the first-line chemotherapy. After first-line treatment, temozolomide will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
Re-staging will be performed every 2 cycles (every 8 weeks) during the study, radiotherapy was allowed. Receives: Drug: Temozolomide; Drug: first-line chemotherapy; Radiation: Prophylactic cranial irradiation; Radiation: thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS of the maintenance therapy
from the data of randomized to the date of disease progression or the patient dies
Measured: 2 years
Secondary outcomes (2)
PFS
from the date of first-line chemotherapy to the date of disease progression
Measured: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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 posted13 May 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yihu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772107
- Sponsor's protocol ID
- 301PLAGH
- Status last verified
- May 2016
- First submitted
- 7 May 2016
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02772107
- Acronym / sponsor ID
- 301PLAGH
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Keywords
- Small Cell Lung Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 13 May 2016 (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.
Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSC group | Experimental | Drug: first-line chemotherapy, Radiation: Prophylactic cranial irradiation, Radiation: thoracic radiotherapyPatients in the study will receive the following for the duration of the study:First-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cycles of therapy for the first-line chemotherapy. Radiotherapy was allowed. Follow-up until disease progression. |
| TMZ group | Experimental | Drug: Temozolomide, Drug: first-line chemotherapy, Radiation: Prophylactic cranial irradiation, Radiation: thoracic radiotherapyPatients will receive platinum-based first-line chemotherapy according to the NCCN guidelines. The study will consist of 21-day cycles, to a maximum of 6 cyclesfor the first-line chemotherapy. After first-line treatment, temozolomide will be given alone as maintenance therapy in all patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs. Re-staging will be performed every 2 cycles (every 8 weeks) during the study, radiotherapy was allowed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cytologically and/or histologically confirmed small-cell lung cancer with extensive-stage disease
- Patients must have measurable disease, this can include brain metastases
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Adequate bone marrow function, as defined by: absolute neutrophil count (ANC) >1,500/µL; platelets >100,000/µL; hemoglobin >=9.0 g/dL
- Normal organ function, defined as follows: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=2.5 × the upper limit of normal (ULN), or AST and ALT <=5 × the ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin <=1.5 × the ULN; serum creatinine <=1.5 × the ULN
Key exclusion criteria (5 listed)
- Patients who are pregnant or breastfeeding
- Patients receiving other investigational agents
- Patients with leptomeningeal involvement
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition or HIV-positive patients on combination antiretroviral therapy. However, HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy. Excluding patients on HAART is necessary due to the potential for pharmacokinetic interactions with temozolomide.
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 |
|---|---|---|
| TemozolomideTemozolomide is a nonclassic oral alkylating agent. Temozolomide will be given alone as maintenance therapy in patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs. | Drug | TMZ group |
| first-line chemotherapyfirst-line chemotherapy must be platinum-based: cisplatin(75mg/m2 for d1) or carboplatin（AUC 5 for d1) combined with etoposide（100mg/m2 for d1-d3） | Drug | BSC group, TMZ group |
| Prophylactic cranial irradiationProphylactic cranial irradiation was allowed if necessary | Radiation | BSC group, TMZ group |
| thoracic radiotherapythoracic radiotherapy was allowed if necessary | Radiation | BSC group, TMZ group |
Primary outcome
PFS of the maintenance therapy
Time frame: 2 years
from the data of randomized to the date of disease progression or the patient dies
2 secondary outcomes
PFS
Time frame: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
- Individual participant dataSharing planned: Undecided
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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 2/3 study testing Temozolomide, first-line chemotherapy and Prophylactic cranial irradiation in people with Extensive-stage Small Cell Lung Cancer, run by Chinese PLA General Hospital 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 17 May 2016. 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 combined 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.
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 yi hu, PhD (+861066937292, 13718994934@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS of the maintenance therapy (time frame: 2 years). 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 17 May 2016.