Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery
Recruiting
Phase 2
Interventional Study
Head and Neck Squamous Cell Carcinoma
Hypopharyngeal Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma, Spindle Cell Variant
Lip and Oral Cavity Squamous Cell Carcinoma
p16INK4a Negative Oropharyngeal Squamous Cell Carcinoma
Stage III Hypopharyngeal Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Lip and Oral Cavity Cancer AJCC v8
Stage III Oral Cavity Verrucous Carcinoma
Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IVA Hypopharyngeal Carcinoma AJCC v8
Stage IVA Laryngeal Cancer AJCC v8
Stage IVA Lip and Oral Cavity Cancer AJCC v8
Stage IVA Oral Cavity Verrucous Carcinoma
Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 189 (estimated)
- Sponsor
- ECOG-ACRIN Cancer Research Group · Research network
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About This Trial
This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IVA squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by kill…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* PRE-REGISTRATION (STEP 0)
* Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified \[NOS\]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); patholo…
Contacts
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