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An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma


Phase 2
6 Months
18 Years
Open (Enrolling)
Both
Sarcoma

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Trial Information

An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma


Inclusion Criteria:



- childhood and adolescent patients aged >/=6 months to 18 years of age

- metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma

- adequate bone marrow function

- adequate renal and liver function

- adequate blood clotting

Exclusion Criteria:

- previous malignant tumors

- tumor invading major blood vessels

- prior systemic anti-tumor treatment

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:

Event-free survival (defined as time between randomization and disease progression, recurrence, insufficient therapeutic response after 3 cycles of induction therapy, second primary cancer or death of any cause)

Outcome Time Frame:

up to approximately 67 months

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France:AFSSAPS/DEMEB

Study ID:

BO20924

NCT ID:

NCT00643565

Start Date:

July 2008

Completion Date:

July 2019

Related Keywords:

  • Sarcoma
  • Sarcoma

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