NCT02772107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

May 7, 2016

Last Update Submit

May 15, 2016

Conditions

Extensive-stage Small Cell Lung Cancer

Keywords

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

  • PFS of the maintenance therapy

    from the data of randomized to the date of disease progression or the patient dies

    2 years

Secondary Outcomes (2)

  • PFS

    2 years

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    2 years

Study Arms (2)

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 chemotherapyRadiation: Prophylactic cranial irradiationRadiation: 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: TemozolomideDrug: first-line chemotherapyRadiation: Prophylactic cranial irradiationRadiation: thoracic radiotherapy

Interventions

TemozolomideDRUG

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.

TMZ group
first-line chemotherapyDRUG

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）

BSC groupTMZ group
Prophylactic cranial irradiationRADIATION

Prophylactic cranial irradiation was allowed if necessary

BSC groupTMZ group
thoracic radiotherapyRADIATION

thoracic radiotherapy was allowed if necessary

BSC groupTMZ group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

yi hu, PhD

CONTACT

+86106693729213718994934@126.com

haitao tao, PhD

CONTACT

+861066937875whatyouknow@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of oncology

Study Record Dates

First Submitted

May 7, 2016

First Posted

May 13, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2017

Study Completion

January 1, 2018

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

CN(1)