Temozolomide as Maintenance Therapy Following Induction C... | NCT02772107

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: Temozolomide Drug: first-line chemotherapy Radiation: Prophylactic cranial irradiation Radiation: thoracic radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Temozolomide	Drug	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.

Outcomes Module

Measure	Description	Time Frame
PFS of the maintenance therapy	from the data of randomized to the date of disease progression or the patient dies	2 years

Secondary Outcomes

Measure	Description	Time Frame
PFS	from the date of first-line chemotherapy to the date of disease progression	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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Name	Role	Phone	Extension	Email
yi hu, PhD	Contact	+861066937292		13718994934@126.com
haitao tao, PhD	Contact	+861066937875		whatyouknow@126.com

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D003606	Dacarbazine
D014226	Triazenes
D009930	Organic Chemicals
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds