Know Cancer

or
forgot password

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Brain Metastases

Thank you

Trial Information

Phase II Study of Continuous Endostar Infusion Combined With Radiotherapy for the Treatment of Patients With Brain Metastases


Inclusion Criteria:



- Histologically confirmed malignancy with presence of intraparenchymal brain
metastases

- Karnofsky performance status ≥ 40

- Measurable disease according to RECIST criteria

- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L

- Renal function: Cr ≤ 2.0×ULN

- Hepatic function: BIL ≤ 2.0×ULN, ALT/AST ≤ 5.0×ULN

- Adequate cardiac function

- Life expectancy ≥ 3 months

Exclusion Criteria:

- Evidence of bleeding diathesis or serious infection

- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia,
unstable angina, myocardial infarction, serious heart valve disease, resistant
hypertension)

- Uncontrollable mental and nervous disorders

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR)

Outcome Time Frame:

1 month after initial treatment

Safety Issue:

No

Principal Investigator

Xiaodong Jiang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The First People's Hospital of Lianyungang

Authority:

China:SFDA

Study ID:

Endu-201107

NCT ID:

NCT01410370

Start Date:

June 2011

Completion Date:

June 2013

Related Keywords:

  • Brain Metastases
  • Endostar
  • Radiotherapy
  • Brain Metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms

Name

Location