Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

March 27, 2019 updated by: Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University

Radiation Versus Temozolomide in Preventing Brain Metastases in Limited Stage Small Cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We'd like to investigate the 2-year incidence rate of brain metastases in completed or partial remission limited small cell lung cancer patients who received temozolomide only for 12 months or 25-30Gy prophylactic cranial radiotherapy in preventing brain metastases.

Study Type

Interventional

Enrollment (Anticipated)

426

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Haihng Yang, MD

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The first affiliated hospital of Guangzhou MC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histological or cytological diagnosis of small-cll lung cancer histology
  2. 18 years or older
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
  4. Local stage SCLC without distant metastases
  5. After 1st-line chemotherapy (EP or IP) at least 4 cycles
  6. After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
  7. CR or PR assessment by RECIST(1.0) before randomized
  8. Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
  9. 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
  10. Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: temozolomide
temozolomide oral 150mg/m2 d1-5/28d for 12 cycles
Drug: temozolomide
Other Names:
  • Temozolomide Capsules
ACTIVE_COMPARATOR: prophylaxis cranial radiotherapy
prophylaxis cranial radiotherapy,25-30Gy/10Fra
Radiation: prophylaxis cranial radiotherapy
2
Other Names:
  • PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-year incidence of brain metastases
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Investigators

  • Principal Investigator: Hailing Yang, MD, The first affiliated hospital of Guangzhou MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

November 12, 2015

First Submitted That Met QC Criteria

November 13, 2015

First Posted (ESTIMATE)

November 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GACA1501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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