Feasibility of in-vitro testing of chemosensitivity in head and neck carcinoma

Not Applicable

• Conditions: Head and Neck Carcinoma; Cancer - Head and neck

• Registration Number: ACTRN12621000991819
• Lead Sponsor: Chris O'Brien Lifehouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-28
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age equal to 18 years old
-Histological or cytological diagnosis of head and neck carcinoma (HNC)
-Locally advanced, recurrent or metastatic disease that is thought to have a high probability of treatment failure with standard techniques
a.High risk resectable HNC (primary and / or nodal metastases) with sufficient tissue accessible for culture without compromising pathological analysis of the specimen.
b.Unresectable HNC (primary or metastatic) with sufficient tissue accessible for culture via open biopsy or core biopsy.
-ECOG performance status less than or equal to 2.
-Prior systemic therapy is permitted if given more than 6 months prior to study entry in one of the following situations:
•as neoadjuvant therapy;
•as part of definitive chemo-radiotherapy for locally advanced disease; or
•as a component of adjuvant post-surgical treatment.
-Adequate haematological function:
•Hb more than or equal to 90 g/L
•Platelet count more than or equal to 100
•Neutrophil count more than or equal to 1.5
-Adequate biochemical function
•Creatinine less than 1.5 times the upper limit of normal
•AST and / or ALT less than 3 times the upper limit of normal (less than 5 times the upper limit of normal if hepatic metastases present)
•Bilirubin less than 1.5 times the upper limit of normal (unless known Gilberts disease, in which case less than 3 times the upper limit of normal)
-Provision of informed consent.
-Female subjects of childbearing potential have a negative pregnancy test at screening and on Day 1 prior to dosing.
-Female subjects of childbearing potential who are willing to use a highly effective method of birth control or who are surgically sterile or abstain from heterosexual activity for the course of the study and for 6 months after last dose of systemic anticancer therapy.

Exclusion Criteria

-Prior therapy for recurrent and metastatic head and neck squamous cell carcinoma other than as outlined in the inclusion criteria
-Inability to attend for follow up
-Presence of a significant comorbidity that would preclude the use of chemotherapy
-Known active Hepatitis B or C infection or HIV infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified