NCT00652132 (SIOPEL6) is a Phase 3 clinical trial of cisplatin in Liver Cancer, sponsored by University of Birmingham.

Who is sponsoring NCT00652132?

NCT00652132 is sponsored by University of Birmingham.

What drugs are being tested in NCT00652132?

Interventions in NCT00652132: cisplatin, sodium thiosulfate.

What condition does NCT00652132 study?

NCT00652132 studies Liver Cancer, Ototoxicity.

Is NCT00652132 still recruiting?

NCT00652132 is currently completed. Last updated 29 May 2018.

Last reviewed 2018-05-29 · How we verify

NCT00652132: SIOPEL6

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 29 May 2018

What this trial tests

Phase 3 trial testing cisplatin in Liver Cancer in 116 participants. Completed in 28 February 2018.

Timeline

15 December 2007

Primary endpoint
4 September 2017

28 February 2018

Quick facts

Lead sponsor	University of Birmingham
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	116
Start date	15 December 2007
Primary completion	4 September 2017
Estimated completion	28 February 2018
Sites	16 locations across United Kingdom

Drugs / interventions tested

cisplatin (cisplatin) — full drug profile →
sodium thiosulfate (SODIUM THIOSULFATE) — full drug profile →

Conditions studied

Liver Cancer — all drugs for Liver Cancer →
Ototoxicity — all drugs for Ototoxicity →

Sponsor

University of Birmingham

Who can join

Adults 1 Month to 18, any sex, with Liver Cancer or Ototoxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Sodium Thiosulfate for Protection from Cisplatin-Induced Hearing Loss.
Brock PR, Maibach R, Childs M, Rajput K, et al · · 2018 · cited 267× · PMID 29924955 · DOI 10.1056/nejmoa1801109
Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial.
Freyer DR, Chen L, Krailo MD, Knight K, et al · · 2017 · cited 196× · PMID 27914822 · DOI 10.1016/s1470-2045(16)30625-8
Platinum-induced neurotoxicity and preventive strategies: past, present, and future.
Avan A, Postma TJ, Ceresa C, Avan A, et al · · 2015 · cited 159× · PMID 25765877 · DOI 10.1634/theoncologist.2014-0044
Progress in the Development of Preventative Drugs for Cisplatin-Induced Hearing Loss.
Hazlitt RA, Min J, Zuo J. · · 2018 · cited 77× · PMID 29361217 · DOI 10.1021/acs.jmedchem.7b01653
Minimal adjuvant chemotherapy for children with hepatoblastoma resected at diagnosis (AHEP0731): a Children's Oncology Group, multicentre, phase 3 trial.
Katzenstein HM, Langham MR, Malogolowkin MH, Krailo MD, et al · · 2019 · cited 73× · PMID 30975630 · DOI 10.1016/s1470-2045(18)30895-7
Current Strategies to Combat Cisplatin-Induced Ototoxicity.
Yu D, Gu J, Chen Y, Kang W, et al · · 2020 · cited 71× · PMID 32719605 · DOI 10.3389/fphar.2020.00999
The design and screening of drugs to prevent acquired sensorineural hearing loss.
Mukherjea D, Rybak LP, Sheehan KE, Kaur T, et al · · 2011 · cited 45× · PMID 22646075 · DOI 10.1517/17460441.2011.562887
Strategies to reduce the risk of platinum containing antineoplastic drug-induced ototoxicity.
Mukherjea D, Dhukhwa A, Sapra A, Bhandari P, et al · · 2020 · cited 27× · PMID 32757852 · DOI 10.1080/17425255.2020.1806235

Verify or expand the search:

Other trials of cisplatin

Trials testing the same drug.

NCT06694454 — Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immun · Phase 1, PHASE2 · not yet recruiting
NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
NCT06924619 — Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma · Phase 2 · recruiting
NCT06151574 — Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer W · Phase 3 · active not recruiting
NCT06081673 — Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC · Phase 2 · recruiting

Other recruiting trials for Liver Cancer

Currently open trials in the same condition.

NCT07295275 — Safety and Efficacy of Transarterial ICG Fluorescence-Guided Laparoscopic Anatomical Liver Resection · recruiting
NCT07410494 — Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07295340 — Diagnostic Accuracy of Folate-Targeted NIR-II Carbon Dots for Ex Vivo HCC Detection · recruiting
NCT07504367 — Large Language Models Assist in Tumor MDT · NA · recruiting
NCT07447050 — Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial · Phase 2 · recruiting

Other University of Birmingham trials

Trials by the same sponsor.

NCT07160686 — Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment · Phase 3 · not yet recruiting
NCT07446166 — TETANUS Antibody Detection in Saliva Study · NA · not yet recruiting
NCT07294794 — Personalised Pharmacometabolomic-guided Strategy Trial to Optimise Treatment for Hypertension · NA · not yet recruiting
NCT07246356 — Feasibility and Efficacy of GTEP for Birth Trauma · NA · recruiting
NCT06932653 — Reducing Deaths After Surgery in Low- and Middle-income Countries: A Pilot Cluster Randomised Trial · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00652132 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Birmingham
Last refreshed: 29 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00652132.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing