Hepatocellular Carcinoma Clinical Trial
Official title:
Phase III Randomized Double-blind Cross-over Trial of 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
Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian
target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high
level of efficacy with acceptable tolerability. Currently, there are five approved targeted
therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib
(Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma
treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib
will be included, too.
Since this agents have dermatological adverse events in common, with oral mucositis (OM),
hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect,
we require evidence based management options to prevent and treat these adverse events. The
incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus
41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct
from conventional mucositis and more closely resembles aphthous OM.
Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse,
became available to prevent or treat OM.
The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes
which include oral intake, swallowing function and pain associated with incidence of grade ≥
1 oral side effects and the anticancer therapy cessation in patients treated with selected
targeted anticancer therapy.
Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either
Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will
switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration
of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed
weekly with the Modified-VHNSS-version-2.0 oral-specific questionnaire. Patients will be
stratified by targeted anticancer agent and per tumor type (pre-defined cohorts). Objective
severity of oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of
subjective Modified-VHNSS-version-2.0 scores with the objective NCI-CTCAE grade, sex, age,
targeted therapy type, and cancer type will be conducted.
OM with mucosal change, associated pain, and taste change - are clinically relevant
toxicities of TKI's and mTORI's presently in use. The incidence of oral mucositis of any
grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus 41%, and for everolimus
44%.
Optimal antitumor activity requires maintaining the highest tolerable dose in individual
patients. In order to improve health related quality of life (HRQoL) and patient adherence,
adverse effects should be prevented, if possible avoided and treated if necessary. Current
oral formulations consist of various schedules (continuous administration or 4 weeks on, 2
weeks off) to optimize the benefit-risk profile. Adherence to anti-cancer treatment is
particularly important when prescribing oral therapies as adherence to the protocol can have
a significant impact on efficacy and the severity of treatment-related AEs. As sorafenib,
sunitinib, pazopanib, and everolimus are taken in the outpatient setting, patient education
on the correct treatment dosing, usage and the nature, recognition, and severity of AEs is
essential.
Recent data suggest that TKI and mTORI associated OM is different from conventional
chemotherapy related OM. Oral ulceration usually presents as aphthous-like ulcerations and
has in some studies been reported as mucositis. An analysis of the appearance, course, and
toxicity experiences demonstrated that the condition is distinct from conventional mucositis
and more closely resembles aphthous oral mucositis. These TKI/mTORI related ulcers may
represent a dose-limiting toxicity for this new class of agents, especially considering the
fact that even lower grade mucositis with chronic daily dosing may be cumbersome to the
patient and lead to dose reductions. Studies of treatment strategies for aphthous OM may
therefore be important for the dose adherence of TKI and mTORI and for the overall acceptance
of this therapy for patients.
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