Clinical Trial: Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Pilot Phase II Study for Children With Infantile Fibrosarcoma
Brief Summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy work in treating children with fibrosarcoma.
Detailed Summary:
OBJECTIVES:
Primary
- Determine the event-free and relapse-free survival of children with initially unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC) before definitive local control.
Secondary
- Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by observation after local control with positive microscopic margins.
- Determine the event-free and relapse-free survival of patients initially treated with this regimen followed by additional chemotherapy comprising etoposide and ifosfamide after local control with gross positive margins.
- Determine the event-free and relapse-free survival of patients treated with surgery alone.
OUTLINE: This is a pilot, multicenter study. Patients begin treatment according to lesion resectability.
Patients with resectable lesions proceed to surgery.
- Surgery: Patients undergo resection of disease lesions. Patients with clear or microscopically positive margins undergo observation only. Patients with grossly positive margins undergo re-resection if feasible. Patients with grossly positive margins after re-resection or for whom re-resection is not feasible receive chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC).
Patients with unr
Sponsor: Children's Oncology Group
Current Primary Outcome: Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm [ Time Frame: Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years) ]
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Children's Oncology Group
Dates:
Date Received: November 4, 2003
Date Started: November 2004
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014