A Phase 3 interventional study of Cetuximab and RT (70 Gy in 35 fractions) in HPV Positive Oropharyngeal Squamous Cell Carcinoma, sponsored by Trans Tasman Radiation Oncology Group. Status unknown at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Trans Tasman Radiation Oncology Group · Phase 3, Interventional, and Treatment
A standard treatment for patients with head and neck cancer is radiation given with high doses of a chemotherapy drug called cisplatin, given every 3 weeks during the radiation. This treatment is effective but can significantly increase side effects such as difficulty with swallowing, a sore mouth, fatigue, hearing loss, ringing in the ears and kidney failure. In Australia, a commonly used treatment HPV-Associated Oropharyngeal Squamous Cell Carcinoma is a lower dose of cisplatin given weekly during the radiation. The high dose and low dose schedules result in a similar total dose of cisplatin being given during the radiation, but it is thought that the weekly schedule results in fewer side effects while maintaining effectiveness.
Another approach widely used around the world for patients with head and neck cancer, is to administer the antibody, cetuximab, weekly during radiation. Cetuximab has a very different side effect profile to cisplatin, and has been reported to result in less exacerbation of radiation related side effects. Both cetuximab and cisplatin can reduce the growth of a cancer and increase the effectiveness of radiation. Both cisplatin and cetuximab appear to be effective treatments in combination with radiation, but have not been directly compared.
The purpose of this study is to compare the treatment related side effects (both acute and longer term) between the cisplatin and cetuximab regimens. Both treatments would be given with the same dose of radiation therapy over 7 weeks. The results of this trial will help determine the optimal treatment for patients with HPV-Associated Oropharyngeal Squamous Cell Carcinoma.
Human Papilloma Virus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC) is increasing in incidence and has an improved prognosis compared to other head and neck malignancies when treated with standard combination chemoradiation.
The current standard regimen of high dose cisplatin and Radiation Therapy (RT) for head and neck cancer patients results in significant toxicity and is at the limits of tolerance. The excellent prognosis of patients with HPV-positive OPSCC raises concerns about overtreatment with the current standard of care, resulting in unnecessary acute and late morbidity.
Therefore, investigation of chemo-sparing or chemo-modified regimens with RT for HPV-associated OPSCC that do not compromise efficacy is warranted. A number of regimens less intensive than high dose cisplatin are being used in clinical practice for patients with good prognosis HPV OPSCC, but no comparative trials have been performed in this population. The trial population will be restricted to low risk HPV-associated OPSCC.
Trial Arms:
A- RT (70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cetuximab (400 mg/m2 loading dose IV prior to radiation, followed by weekly cetuximab 250 mg/m2 for the duration of the radiotherapy) B- RT(70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cisplatin (40 mg/m2 IV for the duration of the radiotherapy)
Hypothesis: In patients with locally advanced HPV-associated OPSCC, those treated with weekly cetuximab and conventionally fractionated radiotherapy will experience less acute symptom severity than patients receiving weekly cisplatin and conventionally fractionated radiotherapy.
Patients will be followed weekly during treatment, then at 1, 3, 5, 9, 13 weeks post-treatment and at months 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, 48, 54, and 60 post-completion of treatment. Follow-up for the trial will cease when the last patient accrued has a minimum of 2 years follow-up i.e. has attended the 24 months post-treatment review.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 189 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
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Adequate haematological, renal, and hepatic function as defined by,
Exclusion Criteria:
Other cancer that was diagnosed:
RT (70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cetuximab (400 mg/m2 loading dose IV prior to radiation, followed by weekly cetuximab 250 mg/m2 for the duration of the radiotherapy)
Drug: Cetuximab · Radiation: RT (70 Gy in 35 fractions)
RT(70 Gy in 35 fractions, 5 days a week over 7 weeks) with weekly Cisplatin (40 mg/m2 IV for the duration of the radiotherapy)
Radiation: RT (70 Gy in 35 fractions) · Drug: Cisplatin
Symptom Severity
The area under curve of symptom severity between weekly cisplatin and Radiotherapy Therapy (RT) versus weekly cetuximab and RT from baseline to week 20 (13 weeks post-completion of radiotherapy) as measured by M.D. Anderson Symptom Inventory - Head and Neck Module (MDASI-HN).
Time frame: 20 weeks
Symptom severity
Symptom severity measured by MDASI-HN (Symptom Interference Score, Symptom Score, Symptom Clusters and individual item scores at individual time points)and by Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
Time frame: 24 months
Interference of symptoms with daily life
To compare interference of symptoms with daily life using the MDASI-HN Symptom Interference Score and Quality adjusted life years (QALYs) using the EQ-5D-5L
Time frame: 24 mths
Psychological distress
To compare psychological distress measured by FACT-HN domain scores and depression and anxiety scales of Hospital Anxiety and Depression Scale (HADS)
Time frame: 36 months
Impact on Health Related Quality of Life
Time frame: 36 months
Swallowing dysfunction
To compare swallowing dysfunction by Functional swallowing outcome (video fluoroscopy), CTCAE (v4.0) dysphagia, MDASI and FACT questionnaires, enteral feeding rates.
Time frame: 12 months
Speech and dietary function
To compare speech and dietary function as measured by the Performance Status Scale for Head \& Neck Cancer Patients (PSS-HN)
Time frame: 36 months
Clinician-assessed acute and late toxicity
To compare clinician-assessed acute and late toxicity using toxicity grading (CTCAE v4.0) - reported as worst toxicity and as overall acute toxicity burden (T-score)
Time frame: 60 months
Rate of enteral feeding
To compare rate of enteral feeding at 12 months following treatment using Barnard's exact test for the comparison of two proportions
Time frame: 12 months
Hearing impairment
To compare hearing impairment, as measured by total score of the Hearing Handicap Inventory for adults, screening version (HHIA-S) and audiometry (results will be evaluated according to CTCAE 3 and 4 criteria, Brock criteria, Chang criteria and SIOP Boston Ototoxicity Scale).
Time frame: 24 months
Time to locoregional failure
To compare time to locoregional failure primarily determined by evidence of progression or recurrence clinically or radiologically
Time frame: 36 months
Failure-free survival
To compare failure-free survival by clinical and radioloigical assessments
Time frame: 36 months
Overall survival
To compare overall survival by clinical assessment.
Time frame: 60 months
Pattern of disease failure
Pattern of disease failure (locoregional \[recurrence at primary tumour site and/or regional nodes\], distant, both) as assessed radiologically.
Time frame: 36 months
Complete response rate
To compare FDG-PET-CT complete response rate at week 20
Time frame: 20 weeks
Cost of health resource utilisation
To compare cost of health resource utilisation via questionnaires EQ-5D-5L and RTOG return to work questionnaire.
Time frame: 24 months
Work status and time to return to work
To compare work status and time to return to work by RTOG questionnaire
Time frame: 24 months
Potential prognostic markers
To correlate several potential prognostic markers (including but not limited to EGFR protein level, EGFR copy number, ERCC1, plasma hepatocyte growth factor level, and plasma IL-8) with failure-free survival, overall survival and time to locoregional failure.
Time frame: 60 months
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Trans Tasman Radiation Oncology Group