Clinical Trial: Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)

Brief Summary:

RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.

PURPOSE: This phase III trial is studying how well observation and/or combination chemotherapy works after surgery or biopsy in treating young patients with extracranial germ cell tumors.


Detailed Summary:

OBJECTIVES:

  • Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors while maintaining event-free survival.
  • Treat newly diagnosed patients with extracranial germ cell tumors requiring chemotherapy with a carboplatin-based strategy.
  • Develop a common strategy for the treatment of patients with recurrent or progressive extracranial germ cell tumors.
  • Register all cases of mature and immature teratoma.
  • Develop a common strategy for the management of immature and mature teratoma, including follow-up strategies to permit early detection of yolk sac recurrence.

OUTLINE: This is a multicenter study.

Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or surgical resection. Patients with mature or immature teratoma undergo observation. These patients who relapse (i.e., tumor regrowth) may undergo further surgical resection unless tumor markers are significantly elevated. If the tumor markers are significantly elevated, these patients proceed to JEB chemotherapy according to risk group. Patients with all other malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.

  • Low-risk group: Patients with normal tumor markers undergo observation. Patients with rising tumor markers only AND no imageable tumor proceed to treatment as in the intermediate-risk group. Patients with rising tumor markers AND/OR imageable tumor are considered to have relapsed and proceed to treatment as in the intermediate- or high-risk group.
  • Event-free survival
  • Continuation of treatment
  • Development of common and follow-up strategies
  • Registration of all cases of mature and immature teratoma


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 10, 2006
Date Started: May 2005
Date Completion:
Last Updated: September 16, 2013
Last Verified: June 2009