Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer
NCT ID: NCT02772107
Last Updated: 2016-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
132 participants
INTERVENTIONAL
2015-12-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BSC group
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.
first-line chemotherapy
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 irradiation
Prophylactic cranial irradiation was allowed if necessary
thoracic radiotherapy
thoracic radiotherapy was allowed if necessary
TMZ group
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.
Temozolomide
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 chemotherapy
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 irradiation
Prophylactic cranial irradiation was allowed if necessary
thoracic radiotherapy
thoracic radiotherapy was allowed if necessary
Interventions
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Temozolomide
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 chemotherapy
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 irradiation
Prophylactic cranial irradiation was allowed if necessary
thoracic radiotherapy
thoracic radiotherapy was allowed if necessary
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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yihu
chief of oncology
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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301PLAGH
Identifier Type: -
Identifier Source: org_study_id
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