Phase III study of reduced therapy in the treatment of children with low and intermediate risk extracranial germ cell tumors

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00053352

2. Intervention

   Tumor resection

3. Intervention

   Cancer chemotherapy

4. Additional Topic(s)

   Chemotherapy administration and dosage

5. Resource Description

   Germ cell tumors are tumors arising from primitive germ cells or the cells that would become sperm in the male or an egg in a female. These tumors can occur in the gonads (ovaries in females or the testes in males) and in other areas of the body such as the brain, chest or abdomen. All malignant germ cell tumors will be on this study excluding brain. The overall goal of this study is to see if we can identify patients who have no further need of therapy after a complete resection at surgery, and among those who need chemotherapy, if we can maintain excellent survival rates with a reduced amount of chemotherapy. If a germ cell tumor is completely resected during surgery, chemotherapy may not be necessary. Researchers want to know if they can (1) treat Stage I, testicular/ovarian germ cell tumors by using surgery and close observation, reserving chemotherapy for those who relapse (2) reduce the amount of chemotherapy (3 cycles instead of 4) and give the chemotherapy over a shorter interval (3 days instead of 5) (3) to determine any biologic factors that are unique in the tumors of patients with these tumors

6. Contact

   Berenberg, Jeffrey

7. PI

   Wilkinson, Robert, M.D.

8. Topic

   germ cell and embryonal cancer

9. Study Population

   Males and females 21 years of age or less at diagnosis, except patients with testicular primary tumors, who must be less than 15 years of age.

10. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=269433&version=healthprofessional

11. Website(s)

    http://www.curesearch.org/ArticleView2.aspx?id=7344&l=8673

12. Funded by

    Children's Oncology Group

13. Phase

    Phase 3 clinical trial

14. Performed by

    Clinical Protocol & Data Management Shared Resource