Clinical Trial: Cisplatin With or Without Sodium Thiosulfate in Treating Young Patients With Stage I, Stage II, or Stage III Childhood Liver Cancer

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Multi-centre Open-label Randomised Phase III Trial of the Efficacy of Sodium Thiosulphate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. It is not yet known whether giving sodium thiosulfate is effective in reducing hearing damage caused by cisplatin in treating young patients with liver cancer.

PURPOSE: This randomized phase III trial is studying how well sodium thiosulfate works to decrease hearing loss caused by cisplatin in treating young patients with stage I, stage II, or stage III childhood liver cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • To assess the efficacy of sodium thiosulfate (STS) to reduce the hearing impairment caused by cisplatin chemotherapy.

Secondary

  • To carefully monitor any potential impact of STS on response to cisplatin and survival.
  • To assess the short- and long-term tolerability of the combination of STS and cisplatin
  • To prospectively evaluate and validate biological, radiological and pathological features of standard-risk hepatoblastoma for future risk adapted management
  • To investigate the effect of STS on the formation of cisplatin-DNA adducts.
  • To prospectively collect patient DNA specifically for the analysis of possible genetic factors that may contribute to the development of treatment-related ototoxicity and nephrotoxicity

OUTLINE: This is a multicenter study. Patients are stratified according to country, median age (< 15 months vs ≥ 15 months), and PRETEXT tumor classification (I vs II vs III). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (Neoadjuvant and adjuvant cisplatin): Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 2 weeks for 4 courses. Patients with progressive disease after course 4 are taken off study. Patients without evidence of disease progression proceed to surgery. Beginning within 3 weeks after surgery, patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 2 weeks for 2 courses in t
    Sponsor: Children's Cancer and Leukaemia Group

    Current Primary Outcome: Rate of Brock grade ≥ 1 hearing loss determined after end of trial treatment or at an age of at least 3.5 years

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Response to preoperative chemotherapy
    • Complete resection
    • Complete remission
    • Event-free survival (EFS)
    • Overall survival (OS)
    • Toxicity as graded by CTCAE v 3.0
    • Long-term renal clearance
    • Feasibility of central audiology review


    Original Secondary Outcome: Same as current

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: April 2, 2008
    Date Started: December 2007
    Date Completion:
    Last Updated: August 9, 2013
    Last Verified: June 2009