Squamous Cell Carcinoma of the Head and NeckPhase 1NCT02158234
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck
A Phase 1 study testing Cisplatin and Stereotactic Body Radiation Therapy (SBRT) in people with Squamous Cell Carcinoma of the Head and Neck, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Cisplatin and Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2014to 24 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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
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.
Read the 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.
- Being tested
- Cisplatin, Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- squamous cell carcinoma, head and neck cancer, paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx, hypopharynx, salivary glands, cervical lymph nodes
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Head and Neck Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Also called chemotherapy, cis-diamminedichloroplatinum, CDDP, alkylating agent
Cisplatin 15 mg/m^2 prior to each fraction
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called stereotactic ablative radiotherapy, radiation therapy
All participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: SBRT and Cisplatin | Experimental | Stereotactic Body Radiation Therapy (SBRT) and Cisplatin. Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy/ Cisplatin 15 mg/m^2 Receives: Drug: Cisplatin; Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months
Secondary outcomes (2)
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.
Measured: Up to 24 months
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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start16 Jul 2014
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jimmy Caudell, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158234
- Sponsor's protocol ID
- MCC-17799
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2014
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02158234
- Acronym / sponsor ID
- MCC-17799
- Keywords
- squamous cell carcinoma, head and neck cancer, paranasal sinuses, nasal cavity, nasopharynx, oropharynx, oral cavity, larynx
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: SBRT and Cisplatin | Experimental | Drug: Cisplatin, Radiation: Stereotactic Body Radiation Therapy (SBRT)Stereotactic Body Radiation Therapy (SBRT) and Cisplatin. Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy/ Cisplatin 15 mg/m^2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinAlso: chemotherapy, cis-diamminedichloroplatinum, CDDP, alkylating agentCisplatin 15 mg/m^2 prior to each fraction | Drug | Dose Escalation: SBRT and Cisplatin |
| Stereotactic Body Radiation Therapy (SBRT)Also: stereotactic ablative radiotherapy, radiation therapyAll participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy. | Radiation | Dose Escalation: SBRT and Cisplatin |
Primary outcome
Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT)
Time frame: Up to 24 months
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.
2 secondary outcomes
Local Control Rate
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jimmy Caudell, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cisplatin and Stereotactic Body Radiation Therapy (SBRT) in people with Squamous Cell Carcinoma of the Head and Neck, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.