NCT02605811

Brief Summary

To investigate the response of temozolomide versus prophylactic cranial radiotherapy in preventing brain metastases in completed or partial remission limited small cell lung cancer patients.

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
426

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_2

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

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

4.3 years

First QC Date

November 12, 2015

Last Update Submit

March 27, 2019

Conditions

Small Cell Lung CancerMetastatic Carcinoma

Keywords

limited small cell lung cancerbrain metastasesprophylactic cranial radiotherapytemozolomide

Outcome Measures

Primary Outcomes (1)

  • 2-year incidence of brain metastases

    2 year

Study Arms (2)

temozolomide

EXPERIMENTAL

temozolomide oral 150mg/m2 d1-5/28d for 12 cycles

Drug: temozolomide

prophylaxis cranial radiotherapy

ACTIVE COMPARATOR

prophylaxis cranial radiotherapy,25-30Gy/10Fra

Radiation: prophylaxis cranial radiotherapy

Interventions

temozolomideDRUG
Also known as: Temozolomide Capsules
temozolomide
prophylaxis cranial radiotherapyRADIATION

2

Also known as: PCI
prophylaxis cranial radiotherapy

Eligibility Criteria

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

You may qualify if:

  • Histological or cytological diagnosis of small-cll lung cancer histology
  • years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
  • Local stage SCLC without distant metastases
  • After 1st-line chemotherapy (EP or IP) at least 4 cycles
  • After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
  • CR or PR assessment by RECIST(1.0) before randomized
  • Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5\^9/L, platelets 100 x 10\^9/L
  • Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
  • Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

You may not qualify if:

  • Mixed non-small cell lung cancer histology
  • Neck and supraclavicular lymph node metastasis
  • Be allergic to temozolomide or intolerable to radiotherapy
  • Any unstable systemic disease
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of Guangzhou MC

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung CarcinomaCarcinomaBrain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Hailing Yang, MD

    the first affiliated hospital of Guangzhou MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haihong Yang, MD

CONTACT

862083062825bjrf2009@yahoo.com

Haihng Yang, MD

CONTACT

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
Associate Chief Physician

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 16, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2021

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations

CN(1)