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Status unknownNCT02605811Updated Mar 28, 2019

Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer

A Phase 2 interventional study of temozolomide and prophylaxis cranial radiotherapy in Small Cell Lung Cancer and Metastatic Carcinoma, sponsored by Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by Guangzhou Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
426
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Small Cell Lung Cancer
  • Metastatic Carcinoma

Keywords

  • limited small cell lung cancer
  • brain metastases
  • prophylactic cranial radiotherapy
  • temozolomide
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 426 is above the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Guangzhou Medical University is the lead sponsor of 40 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
426 participants (estimated)

Study arms

  • Experimental
    temozolomide

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

    Drug: temozolomide

  • Active comparator
    prophylaxis cranial radiotherapy

    prophylaxis cranial radiotherapy,25-30Gy/10Fra

    Radiation: prophylaxis cranial radiotherapy

Interventions

  • Drugtemozolomide

    Also known as: Temozolomide Capsules

  • Radiationprophylaxis cranial radiotherapy

    2

    Also known as: PCI

06

What researchers measure

Primary outcomes

  1. 2-year incidence of brain metastases

    Time frame: 2 year

07

Study locations

1 of 1 sites recruiting
  • The first affiliated hospital of Guangzhou MC
    Guangzhou, Guangdong 510120, China
    • Haihong Yang, Dr. · Contact · bjrf2009@yahoo.com · 0862083062825
    • Haihong Yang, Dr. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02605811
Lead sponsor
Guangzhou Medical University
Responsible party
Haihong Yang, MD, Pricipal investigator (Associate Chief Physician, Guangzhou Medical University) — Principal investigator
First posted
Nov 16, 2015
Start date
Sep 2015
Primary completion
Dec 2019 (estimated)
Completion
Dec 2021 (estimated)
Last update
Mar 28, 2019

Study contacts

Haihong Yang, MD
Contact
bjrf2009@yahoo.com
862083062825
Haihng Yang, MD
Contact
Hailing Yang, MD
principal investigator · the first affiliated hospital of Guangzhou MC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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