DAHANCA 28A: Phase I/II Study on Accelerated, Hyperfractionated Radiotherapy With Concomitant Cisplatin and Nimorazole

Danish Head and Neck Cancer Group31 enrolled

Overview

P16 negative cancers continue to have a dismal prognosis despite advances in the treatment of head and neck cancer. Acceleration, dose-escalation, hyperfractionation, chemotherapy and nimorazole has been shown to improve local control. The purpose of the study i to investigate the level of co-morbidity and performance status (PS) that allows the combination of all of the above means of treatment intensification

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HNSCC,Larynx, Pharynx and Oral Cavity

Interventions

76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazoleRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Squamous Cell Carcinoma head and neck cancer of the pharynx, larynx and oral cavity * P16 negative * T1-4 * N1-3 * M0 * Organ function and performance status allowing radical chemo-radiotherapy Exclusion Criteria: * None

Locations (4)

Aarhus

Aarhus, Aarhus C, Denmark

Odense

Odense, Odense C, Denmark

Aalborg

Aalborg, Denmark

Herlev

Herlev, Denmark

Outcomes

Primary Outcomes

Compliance

Proportion of patients that receive radiotherapy in accordance to prescribed dose and treatment time

Time frame: End of radiotherapy (approximately 5.5 weeks after start of radiotherapy)

Secondary Outcomes

Acute toxicity

In accordance with the Danish Head and Neck Cancer Group (DAHANCA) toxicity scales

Time frame: 2 months after end of radiotherapy

Response rate

Proportion of complete and partial responders

Time frame: 2 months after end of radiotherapy

Data from ClinicalTrials.gov

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