Clinical Trial 17799

Cancer Type: Head & Neck
Interventions:cisplatin

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Jimmy Caudell

Overview

Study Title

A Phase I Dose Escalation Trial of Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of the Head and Neck

Summary

This study involves another course of radiation (called re-irradiation) to the participant's tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of radiation will work best in controlling the growth of head/neck cancer. The usual treatment for head/neck cancer that has grown is surgery and/or more radiation with various chemotherapy drugs.

Objective

1. Define the maximum tolerated dose (MTD) of SBRT with concurrent cisplatin for reirradiation of locally or regionally recurrent, unresectable head and neck cancer. 2. Secondary objectives include local control, survival, and quality of life.

Inclusion Criteria

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  • Age ≥ 18 years
  • Recurrence of previously pathologically proven squamous cell carcinoma of the head and neck, including original primary sites in the paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, and/or involvement of cervical lymph nodes
  • Prior radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥ 6 months prior to enrollment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
  • Life expectancy > 6 months
  • Medically unfit for surgery or deemed surgically unresectable by head and neck (H&N) surgeon within 60 days prior to enrollment, or patient refusal of surgery
  • Normal organ and marrow function
  • No prior evidence of Grade 3 or greater toxicity or neuropathy
  • Medically fit to receive cisplatin

  • Exclusion Criteria

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  • Women who are pregnant or breastfeeding. Women of childbearing potential or sexually active males must be willing to use effective contraception throughout their participation in the treatment phase of the study.
  • Evidence of distant metastases
  • Tumor size > 7 cm in one direction
  • Tumor within 1 cm of the spinal cord
  • Cardiac history: class III or greater congestive heart failure (CHF) or myocardial infarction (MI) within last 6 months
  • Medical condition or social situation that at the discretion of the principal investigator (PI) would preclude them from completion of the trial