Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck

H. Lee Moffitt Cancer Center and Research Institute

Status and phase

Completed

Phase 1

Conditions

Squamous Cell Carcinoma of the Head and Neck

Treatments

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02158234

MCC-17799

Details and patient eligibility

About

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.

Full description

Stereotactic Body Radiation Therapy (SBRT) is a relatively new radiation technique in which a few very high doses of radiation are delivered to small, well-defined tumors. It has been used effectively in other cancers like lung and liver. The goal is to deliver a radiation dose that is high enough to kill the cancer while limiting radiation to surrounding healthy organs. The daily dose of radiation is 2-3 times greater than conventional radiotherapy, but it is given for only 5 days over a 2 week period. Conventional radiotherapy is given over 6-7 weeks. The chemotherapy drug, cisplatin is used as a radiation sensitizer and will be given before each of the 5 radiation treatments.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Positive urine pregnancy test and/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