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

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ClinicalTrials.gov Identifier: NCT02772107
Recruitment Status : Unknown
Verified May 2016 by yihu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
yihu, Chinese PLA General Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Extensive-stage Small Cell Lung Cancer Drug: Temozolomide Drug: first-line chemotherapy Radiation: Prophylactic cranial irradiation Radiation: thoracic radiotherapy Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : January 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: 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）

Radiation: Prophylactic cranial irradiation
Prophylactic cranial irradiation was allowed if necessary

Radiation: thoracic radiotherapy
thoracic radiotherapy was allowed if necessary
Experimental: 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.

 Drug: 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.

Drug: 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）

Radiation: Prophylactic cranial irradiation
Prophylactic cranial irradiation was allowed if necessary

Radiation: thoracic radiotherapy
thoracic radiotherapy was allowed if necessary


Outcome Measures
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Primary Outcome Measures :
  1. PFS of the maintenance therapy [ Time Frame: 2 years ]
    from the data of randomized to the date of disease progression or the patient dies


Secondary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]
    from the date of first-line chemotherapy to the date of disease progression

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2 years ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772107


Contacts
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Contact: yi hu, PhD +861066937292 13718994934@126.com
Contact: haitao tao, PhD +861066937875 whatyouknow@126.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: haitao tao, PhD    +861066937875    whatyouknow@126.com   
Sponsors and Collaborators
Chinese PLA General Hospital
More Information
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Responsible Party: yihu, chief of oncology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02772107    
Other Study ID Numbers: 301PLAGH
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by yihu, Chinese PLA General Hospital:
Small Cell Lung Carcinoma
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents