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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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 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 was allowed if necessary
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGPFS of the maintenance therapy
from the data of randomized to the date of disease progression or the patient dies
Time frame: 2 years
PFS
from the date of first-line chemotherapy to the date of disease progression
Time frame: 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
Time frame: 2 years
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thoracic radiotherapy was allowed if necessary