RecruitingPhase 3ACTRN12613000279729

TROG 12.01 A Randomised Trial of Weekly Cetuximab and Radiation versus Weekly Cisplatin and Radiation in Good Prognosis Locoregionally Advanced HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Sponsor

Trans-Tasman Radiation Oncology Group

Enrollment

200 participants

Start Date

Jun 17, 2013

Study Type

Interventional

Conditions

HPV positive Oropharyngeal Squamous Cell Carcinoma (OPSCC)

Summary

This study aims to compare radiation treatment combined with either cetuximab or cisplatin in patients with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC) (located at the base of tongue or tonsil) Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC). You should not have received any prior treatment for this cancer. Trial details; Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive radiation treatment 5 days a week over 7 weeks, in conjunction with weekly doses of a drug called cetuximab. This drug is administered intravenously, i.e. directly into the vein. Participants in the other group will receive radiation treatment 5 days a week over 7 weeks in combination with the chemotherapy drug cisplatin, which is also administered intravenously. Participants will be assessed 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. Assessments will involve blood tests, questionnaires, clinical examination, hearing tests, swallowing tests, and radiological examination. The main research question being answered is whether those treated with weekly cetuximab and conventionally fractionated radiotherapy will experience less acute symptom severity than patients receiving weekly cisplatin and conventionally fractionated radiotherapy.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is for people who have been diagnosed with a type of throat cancer called HPV-positive oropharyngeal squamous cell carcinoma — cancer that is linked to the human papillomavirus (HPV) and found in the tonsils or base of the tongue. Because HPV-related cancers often respond well to treatment, researchers are asking whether a targeted drug called cetuximab might cause fewer harsh side effects during radiation treatment compared to the standard chemotherapy drug cisplatin, while still being effective. You may be eligible if: - You are 18 years of age or older - You have been diagnosed with HPV-positive (p16 positive) squamous cell carcinoma of the oropharynx - Your cancer is Stage III or IV (but not T4, N3, or spread to distant organs) - You have not previously been treated for this cancer - Your blood counts, kidney, and liver function are adequate - You have a good general health status (ECOG 0–1) - You are willing and able to use contraception during and for 6 months after treatment You may NOT be eligible if: - You have cancer that has spread to distant parts of the body - You have previously had radiotherapy to the same area, cisplatin, carboplatin, or EGFR-targeted therapy - You are pregnant or breastfeeding - You have significant hearing loss, nerve damage, tinnitus, or serious heart or lung conditions - You are HIV positive - You have had another cancer within 5 years (with some exceptions) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Radiation Treatment: 70 Gy in 35 fractions, 5 days a week over 7 weeks. Systemic Treatment: Weekly Cetuximab (400 mg/m2 loading dose IV prior to radiation, followed by weekly cetuximab 250 mg/m2 for

Radiation Treatment: 70 Gy in 35 fractions, 5 days a week over 7 weeks. Systemic Treatment: Weekly Cetuximab (400 mg/m2 loading dose IV prior to radiation, followed by weekly cetuximab 250 mg/m2 for the duration of the radiotherapy)