AGCT1532: Phase 3 Accelerated BEP Trial:A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours

Contact:

NCT Number:

Protocol:

AAAT3563

Study Status:

Active/Enrolling

Population:

Pediatrics/Adult

Phase:

III

This is a study for patients between 11 years and 45 years who have newly diagnosed intermediate or poor-risk metastatic germ cell tumors (GCTs). This study is looking at whether giving treatment with Bleomycin, Etoposide, and Cisplatin (BEP)every 2 weeks (accelerated BEP) or every 3 weeks (standard BEP) is better. Participants will be randomized to either Arm A: standard BEP or Arm B: accelerated BEP. All participants will receive a medication to stimulate the body to make white blood cells which has allowed some chemotherapy regimens to be given with a shorter than usual cycle length, while maintaining the usual doses of the chemotherapy (an accelerated regimen). It is thought that such accelerated regimens may better counteract the rapid growth of tumors such as GCTs, and overcome the quick regrowth of tumors induced by anti-cancer treatment, which is associated with the emergence of drug-resistant clones and treatment failure.

Are you Eligible? (Inclusion Criteria)

  • Patient must be between 11 and 45 years of age at the time of randomization.
  • Patient must have a histologically or cytologically confirmed germ cell tumor or exceptionally raised tumor markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation.
  • Patient must have metastatic disease with primary arising in testis, ovary, retro-peritoneum or mediastinum.
  • Patient must have intermediate or poor prognosis as defined by IGCCC classification.
  • Patient must also meet all other eligibility criteria as outlined in the study protocol.

Specialty Area(s)

Ovarian Cancer, Testicular Cancer, Childhood and Adolescent Cancers (Pediatric)

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032