Phase III Randomized Double-blind Cross-over trial of Supersaturated Calcium-phosphate rinse (Caphosol®) versus NaCl 0.9% in the relief of Oral Mucositis in renal cell carcinoma, hepatocellular carcinoma, and gastrointestinal stromal tumor patients receiving Targeted Therapy - COMTT

• Conditions: oral mucositis in renal cell carcinoma, hepatocellular carcinoma, and gastrointestinal stromal tumor; MedDRA version: 12.1Level: LLTClassification code 10028127Term: Mucositis; MedDRA version: 12.1Level: LLTClassification code 10042128Term: Stomatitis; MedDRA version: 12.1Level: PTClassification code 10042128Term: Stomatitis; MedDRA version: 12.1Level: LLTClassification code 10031009Term: Oral pain; MedDRA version: 12.1Level: PTClassification code 10031009Term: Oral pain; MedDRA version: 12.1Level: LLTClassification code 10013911Term: Dysgeusia; MedDRA version: 12.1Level: PTClassification code 10013911Term: Dysgeusia; MedDRA version: 12.1Level: LLTClassification code 10013950Term: Dysphagia; MedDRA version: 12.1Level: PTClassification code 10013950Term: Dysphagia

• Registration Number: EUCTR2010-024425-20-NL
• Lead Sponsor: eiden University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?Male and female subjects
?=18 years of age
?Histological proof of RCC, HCC or GIST
?Oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry
?Written informed consent
?Eastern Co-operative Oncology Group (ECOG) performance status = 2
?Able to perform oral rinsing
?Able to complete questionnaires by themselves or with assistance

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Subjects meeting any of the following criteria will be excluded from the study:
?Any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy
?Current antineoplastic combination cytotoxic chemotherapy therapy
?Physiologic condition that precludes the use of an oral rinse
?Hypersensitivity to Caphosol ingredients
?Use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy
?Oral abnormalities defined as baseline oral assessment of NCI-CTCAE v4.0 grade > 0
?Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified