Radiation Therapy With or Without Cisplatin for Head and Neck Cancer

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.
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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
Who this trial is looking for

This trial is looking for patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery. Participants will receive radiation therapy, possibly combined with a chemotherapy drug called cisplatin, to see which treatment works better.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with squamous cell carcinoma of the head or neck.
  • I have had surgery to completely remove my tumor.
  • I have tested negative for HPV if my cancer is in the oropharynx.
  • I have not received chemotherapy in the last two years.
  • I am disease-free from any previous cancer for at least two years.
  • I am physically well enough to participate in the trial.

You may not be able to join if

  • I have had positive tumor margins after surgery.
  • I have had any radiation treatment to my head or neck before.
  • I have recurrent cancer or multiple primary cancers.
  • I am pregnant or breastfeeding.
  • I have an illness that could interfere with the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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…
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