Back to results

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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cisplatin

Stereotactic Body Radiation Therapy (SBRT)

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring squamous cell carcinoma, head and neck cancer, paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, cervical lymph nodes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation: SBRT and Cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT)

The traditional 3+3 dose escalation method will be utilized for this phase I study, with up to 3 sequential cohorts. The maximal tolerated dose (MTD) of Stereotactic Body Radiation Therapy (SBRT) radiation dose associated with a ≤ 33% probability of dose-limiting toxicity (DLT). DLT is defined as any grade 4 or greater toxicity, per The Common Terminology Criteria for Adverse Events v4 (CTCAE v4) that occurs within 3 months from the start of SBRT.

Secondary Outcome Measures

Local Control Rate

Local control is defined as lack of progression as defined radiographically or pathologically proven within the SBRT treated area. This will be calculated via Kaplan-Meier method. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria.

Overall Survival (OS)

Overall survival will be calculated from the end of SBRT treatment to time of death or last contact via Kaplan-Meier method.

Full Information

NCT ID

NCT02158234

First Posted

June 4, 2014

Last Updated

January 18, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT02158234

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

July 16, 2014 (Actual)

Primary Completion Date

August 24, 2021 (Actual)

Study Completion Date

August 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Head and Neck

Keywords

squamous cell carcinoma, head and neck cancer, paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, cervical lymph nodes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation: SBRT and Cisplatin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

chemotherapy, cis-diamminedichloroplatinum, CDDP, alkylating agent, cisplatinum

Intervention Description

Cisplatin 15 mg/m^2 prior to each fraction

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Other Intervention Name(s)

stereotactic ablative radiotherapy, radiation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT)

Description

Time Frame

Up to 24 months

Secondary Outcome Measure Information:

Title

Local Control Rate

Description

Time Frame

Up to 24 months

Title

Overall Survival (OS)

Description

Overall survival will be calculated from the end of SBRT treatment to time of death or last contact via Kaplan-Meier method.

Time Frame

Up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

H. Lee Moffitt Cancer Center and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

H. Lee Moffitt Cancer Center and Research Institute

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs