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

NCT ID: NCT02158234

Last Updated: 2023-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-16
• Study Completion Date: 2021-08-24

Brief 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.

Detailed 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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation: SBRT and Cisplatin

Stereotactic Body Radiation Therapy (SBRT) and Cisplatin. Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy/ Cisplatin 15 mg/m\^2

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

Cisplatin 15 mg/m\^2 prior to each fraction

Stereotactic Body Radiation Therapy (SBRT)

Intervention Type: RADIATION

All participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy.

Interventions

Cisplatin

Cisplatin 15 mg/m\^2 prior to each fraction

Intervention Type: DRUG

Stereotactic Body Radiation Therapy (SBRT)

All participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy.

Intervention Type: RADIATION

Other Intervention Names

chemotherapy; cis-diamminedichloroplatinum; CDDP; alkylating agent; cisplatinum; stereotactic ablative radiotherapy; radiation therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jimmy Caudell, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-17799

Identifier Type: -

Identifier Source: org_study_id