HPV Positive Oropharyngeal Squamous Cell CarcinomaPhase 3HPVOropharynxNCT01855451
Weekly Cetuximab/RT Versus Weekly Cisplatin/RT in HPV-Associated Oropharyngeal Squamous Cell Carcinoma
A Phase 3 study testing Cetuximab, RT (70 Gy in 35 fractions) and Cisplatin in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Trans Tasman Radiation Oncology Group at 16 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV Positive Oropharyngeal Squamous Cell Carcinoma
- What is being tested?
- Cetuximab, RT (70 Gy in 35 fractions) and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 3 Jun 2013to 23 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Has provided written Informed Consent for participation in this trial
- Histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive status confirmed locally by immunohistochemistry
- Stage III (excluding T1-2N1) or stage IV (excluding T4, N3, and distant metastasis) if smoking history of < /=10 pack years. If > 10 pack years nodal disease must be N0 - N2a.
- If an excisional biopsy has been performed, patients remain eligible for the study provided there is clinically measurable disease prior to commencing RT. The residual disease should still meet the stage criteria required for the trial e.g. excisional biopsy of a node with residual T3 primary, or tonsillectomy for T1 primary with residual > N2a nodes.
- No prior treatment for oropharyngeal cancer
Show all 17Show fewer
- Adequate haematological, renal, and hepatic function as defined by,
- Absolute neutrophil count (ANC, segs + bands) > /= 1.5 x 109/L
- Platelet count > /= 100 x 109/L
- Total bilirubin < /= 1.5 x upper normal limit
- ALT < /= 2.5 x upper normal limit
- Calculated creatinine clearance (Cockcroft-Gault formula) or isotopic GFR > 55ml/min
- ECOG performance status score of 0-1
- Participants capable of childbearing are using adequate contraception and intend to continue use of contraception for at least 6 months following completion of treatment
- Negative pregnancy test within 72 hours prior to randomisation of women who are of childbearing potential
- Suitable for follow-up for at least 24 months as per trial protocol.
- Sufficient proficiency in English, cognitive capacity and willingness to complete questionnaires
Who cannot join
- History of unknown primary of the head and neck
- T4, N3 or distant metastases
- Smoking history >10 pack years with N2b or c nodal status
- Women who are pregnant or lactating.
- Previous radiotherapy to the area to be treated (excluding superficial radiotherapy for a cutaneous malignancy)
- Previous cisplatin or carboplatin chemotherapy
Show all 17Show fewer
- Prior EGFR targeted therapy of any kind
- Primary surgery to the affected area (excisional biopsy allowed)
- Peripheral neuropathy > /= grade 2 (CTCAE v4.0)
- Sensori-neural hearing impairment >= grade 2 (CTCAE v4.0, hearing impaired, not enrolled on a monitoring program) which may be exacerbated by cisplatin (Audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion)
- Tinnitus > /= grade 2 (CTCAE v4.0)
- History of interstitial lung disease or evidence of interstitial lung disease on pre-registration CT
- History of myocardial infarction within 12 months prior to study entry, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, uncontrolled psychotic disorders, active serious infections, active peptic ulcer disease, immunosuppression due to post-organ transplantation or use of immunosuppressants for autoimmune disorders
- Patients known to be HIV positive
- Other cancer that was diagnosed:
- more than 5 years prior to current diagnosis with (i) subsequent evidence of disease recurrence or (ii) clinical expectation of recurrence is greater than 10% or
- within 5 years of the current diagnosis, with the exception of successfully treated basal cell or squamous cell skin carcinoma, in situ melanoma, or carcinoma in situ of the cervix
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Australia14 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Canberra Hospital
Canberra, Australian Capital Territory
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Royal Brisbane and Womens Hospital
Herston, Queensland, 4006
Liverpool Hospital
Liverpool, New South Wales, 2170
Austin Hospital
Melbourne N., Victoria, 3084
Sir Charles Gairdner
Nedlands, Western Australia, 6009
St George Hospital
Saint George, New South Wales, 2217
Townsville Hospital
Townsville, Queensland, 4810
Riverina Cancer Care Centre
Wagga Wagga, New South Wales
Calvary Mater Newcastle
Waratah, New South Wales
Westmead Hospital
Westmead, New South Wales, 2145
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand2 sites
Auckland City Hospital
Auckland, 1344
Palmerston North Hospital
Palmerston, 4442
About this study
Official title: TROG12.01 A Randomised Trial of Weekly Cetuximab and Radiation Versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma
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.
Read the detailed description
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.
- Keywords
- Human Papilloma Virus, HPV, Oropharyngeal, Squamous Cell, Carcinoma
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy + Cetuximab | Active comparator | 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) Receives: Drug: Cetuximab; Radiation: RT (70 Gy in 35 fractions) |
| Radiation Therapy + Cisplatin | Active comparator | 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) Receives: Radiation: RT (70 Gy in 35 fractions); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 weeks
Secondary outcomes (17)
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).
Measured: 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
Measured: 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)
Measured: 36 months
Impact on Health Related Quality of Life
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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).
Measured: 24 months
Time to locoregional failure
To compare time to locoregional failure primarily determined by evidence of progression or recurrence clinically or radiologically
Measured: 36 months
Failure-free survival
To compare failure-free survival by clinical and radioloigical assessments
Measured: 36 months
Overall survival
To compare overall survival by clinical assessment.
Measured: 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.
Measured: 36 months
Complete response rate
To compare FDG-PET-CT complete response rate at week 20
Measured: 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.
Measured: 24 months
Work status and time to return to work
To compare work status and time to return to work by RTOG questionnaire
Measured: 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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study start3 Jun 2013
- Primary completion30 Apr 2020
- Study completion23 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV Positive Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D Rischin, Dr, Study chair, TROG and Peter MacCallum Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855451
- Sponsor's protocol ID
- TROG 12.01
- Other IDs
- ACTRN12613000279729
- Acronym
- HPVOropharynx
- Status last verified
- Nov 2022
- First submitted
- 13 May 2013
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rischin D, King M, Kenny L, Porceddu S, Wratten C, Macann A, Jackson JE, Bressel M, Herschtal A, Fisher R, Fua T, Lin C, Liu C, Hughes BGM, McGrath M, McDowell L, Corry J. Randomized Trial of Radiation Therapy With Weekly Cisplatin or Cetuximab in Low-Risk HPV-Associated Oropharyngeal Cancer (TROG 12.01) - A Trans-Tasman Radiation Oncology Group Study. Int J Radiat Oncol Biol Phys. 2021 Nov 15;111(4):876-886. doi: 10.1016/j.ijrobp.2021.04.015. Epub 2021 Jun 4.
PubMed 34098030
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TROG12.01 A Randomised Trial of Weekly Cetuximab and Radiation Versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01855451
- Acronym / sponsor ID
- HPVOropharynx / TROG 12.01
- Keywords
- Human Papilloma Virus, HPV, Oropharyngeal, Squamous Cell, Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 23 Aug 2023 (estimated)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy + Cetuximab | Active comparator | Drug: Cetuximab, Radiation: RT (70 Gy in 35 fractions)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) |
| Radiation Therapy + Cisplatin | Active comparator | Radiation: RT (70 Gy in 35 fractions), Drug: CisplatinRT(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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18 years or older
- Has provided written Informed Consent for participation in this trial
- Histologically confirmed squamous cell carcinoma of the oropharynx with p16 positive status confirmed locally by immunohistochemistry
- Stage III (excluding T1-2N1) or stage IV (excluding T4, N3, and distant metastasis) if smoking history of < /=10 pack years. If > 10 pack years nodal disease must be N0 - N2a.
- If an excisional biopsy has been performed, patients remain eligible for the study provided there is clinically measurable disease prior to commencing RT. The residual disease should still meet the stage criteria required for the trial e.g. excisional biopsy of a node with residual T3 primary, or tonsillectomy for T1 primary with residual > N2a nodes.
Key exclusion criteria (17 listed)
- History of unknown primary of the head and neck
- T4, N3 or distant metastases
- Smoking history >10 pack years with N2b or c nodal status
- Women who are pregnant or lactating.
- Previous radiotherapy to the area to be treated (excluding superficial radiotherapy for a cutaneous malignancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab | Drug | Radiation Therapy + Cetuximab |
| RT (70 Gy in 35 fractions) | Radiation | Radiation Therapy + Cetuximab, Radiation Therapy + Cisplatin |
| Cisplatin | Drug | Radiation Therapy + Cisplatin |
Primary outcome
Symptom Severity
Time frame: 20 weeks
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).
17 secondary outcomes
Symptom severity
Time frame: 24 months
Interference of symptoms with daily life
Time frame: 24 mths
Psychological distress
Time frame: 36 months
Impact on Health Related Quality of Life
Time frame: 36 months
Swallowing dysfunction
Time frame: 12 months
Speech and dietary function
Time frame: 36 months
Clinician-assessed acute and late toxicity
Time frame: 60 months
Rate of enteral feeding
Time frame: 12 months
Hearing impairment
Time frame: 24 months
Time to locoregional failure
Time frame: 36 months
Failure-free survival
Time frame: 36 months
Overall survival
Time frame: 60 months
Pattern of disease failure
Time frame: 36 months
Complete response rate
Time frame: 20 weeks
Cost of health resource utilisation
Time frame: 24 months
Work status and time to return to work
Time frame: 24 months
Potential prognostic markers
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
- Derived from this study: PubMed 34098030Rischin D, King M, Kenny L, Porceddu S, Wratten C, Macann A, Jackson JE, Bressel M, Herschtal A, Fisher R, Fua T, Lin C, Liu C, Hughes BGM, McGrath M, McDowell L, Corry J. Randomized Trial of Radiation Therapy With Weekly Cisplatin or Cetuximab in Low-Risk HPV-Associated Oropharyngeal Cancer (TROG 12.01) - A Trans-Tasman Radiation Oncology Group Study. Int J Radiat Oncol Biol Phys. 2021 Nov 15;111(4):876-886. doi: 10.1016/j.ijrobp.2021.04.015. Epub 2021 Jun 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D Rischin, Dr study chair
TROG and Peter MacCallum Cancer Centre
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cetuximab, RT (70 Gy in 35 fractions) and Cisplatin in people with HPV Positive Oropharyngeal Squamous Cell Carcinoma, run by Trans Tasman Radiation Oncology Group at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.