NCT01874171 · CITED IN SOURCE DOCUMENTS

Determination of Cetuximab Versus Cisplatin Early and Late Toxicity Events in HPV+ OPSCC

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: UNKNOWN
Registry last update: 2017-05-08

Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection. HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good prognosis following treatment. Subsequently, patients can live with the considerable side effects for several decades. Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing platinum-based compounds) in head and neck cancer, but is potentially less toxic. Results of this trial will be used to determine the optimum treatment of this debilitating cancer, with the primary aim of decreasing toxicity and improving quality of life for HPV+OPSCC patients.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part

eligibility Criteria: Inclusion Criteria: * American Joint Committee on Cancer (AJCC) TNM Stage III-IVa (T3N0-T4N0, and T1N1-T4N3) oropharyngeal squamous cell carcinoma (SCC) tumours * Clinical multidisciplinary team decision to treat with primary curative cisplatin chemoradiotherapy * No previous treatment including surgery, except node biopsies or diagnostic tonsillectomy * Medically fit (ECOG 0, 1 or 2) * Adequate cardiovascular, haematological, renal and hepatic function * Age \> 18 years * Written informed consent given * Using adequate contraception \[male and female participants\]. Must take contraceptive measures during, and for at least six months after treatment. Exclusion Criteria: * Distant metastasis (i.e. AJCC TNM stage IVc disease) * AJCC TNM Stage T1-2N0 disease * Treated with primary radical surgery to the primary site (e.g. resection) * Concurrent use of CYP3A4 inducers or inhibitors. \[A standard course of dexamethasone or aprepitant for the prevention of cisplatin-induced nausea and vomiting is permitted\] * Serious cardiac illness or other medical conditions precluding the use of cisplatin or cetuximab \[no history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities; no uncontrolled seizure disorder; no active neurologic disease; no neuropathy greater than grade 1\] * Patients who have p16+ tumours who also have N2b, N2c or N3 nodal disease and whose lifetime smoking history is also more than 10 pack years (i.e. have both risk factors). * Pregnant or lactating * Previous treatment for any other cancer with cytotoxics, radiotherapy or anti-EGFR therapies * Inadequate renal, haematological or liver functions \[Absolute neutrophil count \<1,500/mm3; platelet count \<100,000/mm3; WBC \<3,000/mm3; haemoglobin \<9 g/dL. \[Haemoglobin correction by transfusion permitted.\] Bilirubin \> 1.5 times upper limit of normal (ULN); alkaline phosphatase \> 2.5 times ULN; AST and ALT \> 2.5 times ULN. Creatinine \> 1.5 mg/dL; Creatinine clearance \< 60 mL/min\] * Patients with clinically significant hearing impairment * Life expectancy less than 3 months * Other malignancy within the past 3 years except basal cell skin cancer or pre-invasive carcinoma of the cervix.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Three doses of cisplatin 100mg/m2 given at days 1, 22 and 43 from start of radiotherapy.
intervention Names
Drug: Cisplatin
label
Cisplatin
type
ACTIVE_COMPARATOR
description
Initial dose of 400mg/m2 one week before start of radiotherapy followed by seven weekly doses of 250 mg/m2 during radiotherapy.
intervention Names
Drug: Cetuximab
label
Cetuximab
type
EXPERIMENTAL

interventions

arm Group Labels
Cisplatin
name
Cisplatin
type
DRUG
arm Group Labels
Cetuximab
name
Cetuximab
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 334
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

measure
Compare severe (acute and late) toxicity (Grade 3-5) caused by cetuximab and radiotherapy to that caused by cisplatin and radiotherapy.
time Frame
Up to two years after end of treatment.

secondary Outcomes

measure
Overall number of events of acute severe toxicity between treatment arms.
time Frame
Up to and including three months after end of treatment.
measure
Overall number of events of late severe toxicity between treatment arms.
time Frame
From three months up to two years after end of treatment.
measure
Quality of life outcomes assessed by EORTC QLQ C30 and HN35 between the two treatment arms.
time Frame
Baseline, end of treatment, and 3, 6, 12 & 24 months after end of treatment.
measure
Effect on swallowing of the two treatment arms (assessed by MDADI and by PEG or RIG utilisation rate at 1 and 2 years).
time Frame
Baseline, end of treatment, and 3, 6, 12 & 24 months after end of treatment.
description
Questionnaires completed at the following time points: Baseline, end of treatment, and 3, 6, 12 \& 24 months after end of treatment.
measure
Cost-effectiveness of the two treatment arms (assessed by EuroQoL-5D).
time Frame
Up to two years after end of treatment.
measure
Overall survival and recurrence between the two arms.
time Frame
Up to two years after end of treatment.

Full study description

brief Summary: Oropharyngeal squamous cell carcinoma (OPSCC) incidence is increasing rapidly in the developed world. This has been attributed to a rise in Human Papillomavirus (HPV) infection. HPV+OPSCC is considered a distinct disease entity, affecting younger patients and has a good prognosis following treatment. Subsequently, patients can live with the considerable side effects for several decades. Radiotherapy and cetuximab (Epidermal Growth Factor Receptor-inhibitor) have demonstrated similar efficacy to 'platin' chemoradiotherapy (current standard treatment containing platinum-based compounds) in head and neck cancer, but is potentially less toxic. Results of this trial will be used to determine the optimum treatment of this debilitating cancer, with the primary aim of decreasing toxicity and improving quality of life for HPV+OPSCC patients.

Source references