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Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer

NCT02772107•Chinese PLA General Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 1, 2015

Primary Completion Date

June 1, 2017

Completion Date

January 1, 2018

Last Updated

May 17, 2016

Enrollment

132

ESTIMATED participants

Conditions

Extensive-stage Small Cell Lung Cancer

Interventions

Temozolomide

DRUG

first-line chemotherapy

DRUG

Prophylactic cranial irradiation

RADIATION

thoracic radiotherapy

RADIATION

Contacts

yi hu, PhD

CONTACT

+861066937292 13718994934@126.com

haitao tao, PhD

CONTACT

+861066937875 whatyouknow@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Temozolomide as Maintenance Therapy Following Induction Chemotherapy in Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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