Study on Radiation Therapy With or Without Cisplatin for Patients With Stage III-IVA Head and Neck Cancer After Surgery

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02734537

Provider View

This clinical trial is exploring whether adding the chemotherapy drug cisplatin to radiation therapy can improve treatment outcomes for patients with stage III-IVA squamous cell carcinoma of the head and neck who have had surgery.

Patient Parameters

Program Overview

The purpose of this study is to determine if radiation therapy alone or combined with the chemotherapy drug cisplatin is more effective 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 cancer cells, while cisplatin works by stopping cancer cells from growing and spreading. The study aims to find out which treatment approach is better at preventing the cancer from returning.

Description

The study has two main goals:

  1. To see if patients with stage III-IV squamous cell carcinoma of the head and neck (SCCHN) who have certain genetic changes in their cancer (disruptive p53 mutations) have better disease-free survival when treated with radiation therapy alone or with radiation plus cisplatin after surgery.

  2. To evaluate the side effects of radiation therapy alone compared to radiation with cisplatin.

Patients will be randomly assigned to one of two groups:

  • Group A: Patients will receive radiation therapy once a day, five days a week, for six weeks.
  • Group B: Patients will receive the same radiation therapy plus cisplatin given through an IV once a week for six weeks.

After completing the treatment, patients will have follow-up visits every six months for three years, then once a year for seven more years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of squamous cell carcinoma of the head and neck (including certain variants) at stage III or IVA.
  • Must have had surgery to completely remove the primary tumor with the intent to cure.
  • For oropharynx tumors, the cancer must not be related to HPV.
  • Must not have any remaining cancer at the edges of the removed tumor or any cancer left after surgery.
  • Must provide a tumor tissue sample for genetic testing.
  • Must not have had any other cancer treatment within two years before surgery, except for certain skin or cervical cancers.
  • Must not have had previous radiation to the head and neck that would overlap with the current treatment.
  • Must not have recurrent cancer or multiple primary cancers.
  • Must have a good performance status (ECOG 0-1).
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during the study and for 60 days after the last treatment.
  • Must have adequate blood cell counts and organ function as determined by specific tests.
  • Must not have any other illness that could interfere with the study treatment.

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