Paranasal Sinus NeoplasmsNCT00347256
Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
A study testing cisplatin, targeted radiation therapy and tumor resection in people with Paranasal Sinus Neoplasms, run by University of Tennessee.
Trial summary
The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paranasal Sinus Neoplasms
- What is being tested?
- cisplatin, targeted radiation therapy and tumor resection
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Karnofsky Performance Score: >= 60
- Creatinin clearance >= 50 ml/min or serum creatinine =<1.5 mg/dl
- Total bilirubin, AST, ALT =< 1.5 X laboratory uln
- ANC >= 2000/mm3, platelets >= 100,000/mm3
- Serum calcium within normal range
- T3 or T4 state tumors of paranasal sinuses
- Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma
Who cannot join
- History of other malignancy in the last 3 years
- Other serious comorbidity that may significantly reduce the survival in next 5 years
- Pregnant or lactating women
- History of radiation to the head and neck region
- Paranasal sinus tumor is recurrent after prior treatment
- Presence of cervical node metastasis
- Presence of distant metastasis
- Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion
About this study
Official title: Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.
- Conditions
- Paranasal Sinus Neoplasms
- Being tested
- cisplatin, targeted radiation therapy, tumor resection
- Medical subject headings
- Paranasal Sinus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
targeted radiation therapyProcedure or surgery
tumor resectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control of cancer at two years post treatment
Response to preoperative chemoradiation
Secondary outcomes (5)
Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
Identification of factors that are associated with inoperability
Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paranasal Sinus NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- North American Skull Base Society
- Investigators
- Sandeep Samant, MS, FRCS, Study chair, University of TennesseeSandeep Samant, MS, FRCS, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347256
- Sponsor's protocol ID
- NASBS-PNS001
- Status last verified
- Dec 2008
- First submitted
- 29 Jun 2006
- Last updated
- 10 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
- ClinicalTrials.gov ID
- NCT00347256
- Acronym / sponsor ID
- NASBS-PNS001
- Conditions
- Paranasal Sinus Neoplasms
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- North American Skull Base Society
- First posted
- 4 Jul 2006 (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.
The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Karnofsky Performance Score: >= 60
- Creatinin clearance >= 50 ml/min or serum creatinine =<1.5 mg/dl
- Total bilirubin, AST, ALT =< 1.5 X laboratory uln
- ANC >= 2000/mm3, platelets >= 100,000/mm3
- Serum calcium within normal range
Key exclusion criteria (8 listed)
- History of other malignancy in the last 3 years
- Other serious comorbidity that may significantly reduce the survival in next 5 years
- Pregnant or lactating women
- History of radiation to the head and neck region
- Paranasal sinus tumor is recurrent after prior treatment
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 |
|---|---|---|
| cisplatin | Drug | – |
| targeted radiation therapy | Procedure or surgery | – |
| tumor resection | Procedure or surgery | – |
Primary outcome
Local control of cancer at two years post treatment
Response to preoperative chemoradiation
5 secondary outcomes
Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
Identification of factors that are associated with inoperability
Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2008.
- North American Skull Base Society webpageLink provided by the sponsor.
Related trials for Paranasal Sinus Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Recurrent Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy
Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma
RecruitingPhase 1
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 2
Toripalimab With Chemotherapy for Sinus Cancer
Sinonasal Cancer, Paranasal Sinus Neoplasms
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.
Sandeep Samant, MS, FRCS study chair
University of Tennessee
Sandeep Samant, MS, FRCS principal investigator
University of Tennessee
Questions about this trial
What is this clinical trial studying?
A study testing cisplatin, targeted radiation therapy and tumor resection in people with Paranasal Sinus Neoplasms, run by University of Tennessee.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 10 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Local control of cancer at two years post treatment. The study lists 2 primary outcomes in all. 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 10 Dec 2008; AzTrials last refreshed its copy on 7 Nov 2026.