Head and Neck CancerPhase 3NCT00608205
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
A Phase 3 study testing cisplatin, fluorouracil and radiation therapy in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- cisplatin, fluorouracil and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
- No histologic diagnosis other than squamous cell carcinoma
- A primary site must be identified
- Must have locoregionally confined stage III (excluding T1-2, N1) or stage IV disease
- No evidence of nodal disease below the clavicles or distant hematogenous metastases (M0)
- No stage IVC disease (stage IVB disease allowed)
- Deemed appropriate for definitive non-operative management with curative intent
- Resectable disease is not required
- No primary cancer of the nasopharynx, paranasal sinus, or salivary gland
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC > 3,500/mm³
- Platelet count > 100,000/mm³
- Serum creatinine < 2.0 mg/dL
- Alkaline phosphatase < 2 times normal
- AST < 2 times normal
- Bilirubin ≤ 2.0 mg/dL
- Serum calcium normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No unstable or uncontrolled angina
- No clinically apparent jaundice
- No active infection
- No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ), unless the patient has been continuously disease-free for at least 5 years
- Not a poor compliance risk
- Able to withstand the rigors of intensive treatment
- Available for and compliant with adequate long-term follow-up
PRIOR CONCURRENT THERAPY:
- No prior definitive surgery or radiotherapy for this malignancy
- No prior chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for any disease Patients who have had previous definitive surgery, or radiation therapy for this malignancy, and patients who have had any previous chemotherapy, immunotherapy, or EGF receptor inhibition for any disease are ineligible.
Exclusion Criteria Patients with primary cancers of the nasopharynx, paranasal sinus or salivary gland are ineligible.
Patients with unstable or uncontrolled angina, clinically apparent jaundice, or active infection are ineligible.
Patients with a history of any other malignancy (except squamous or basal cell skin cancer or cervical carcinoma in-situ) are ineligible, unless the patient has been continuously disease-free for at least 5 years.
Patients with any histologic diagnosis other than squamous cell carcinoma are ineligible.
Patients who might be a poor-compliance risk are ineligible.
Pregnant or breastfeeding women are ineligible. Women/men of reproductive potential must be willing to practice acceptable methods of birth control to prevent pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.
Read the detailed description
OBJECTIVES:
- To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil.
- To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens.
- To compare the acute and long-term toxicity of these regimens in these patients.
- To compare the quality of life of patients treated with these regimens.
- To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies.
OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
- Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy.
Patients complete questionnaires periodically to assess late toxicity and quality of life.
After completion of study treatment, patients are followed periodically.
- Conditions
- Head and Neck Cancer
- Being tested
- cisplatin, fluorouracil, radiation therapy
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the larynx
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Also called CDDP
Given IV
fluorouracilDrug
Given IV
radiation therapyRadiation
Also called radiation
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Radiation with concurrent Cisplatin | Active comparator | Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. Receives: Drug: cisplatin; Radiation: radiation therapy |
| Arm B: Radiation with concurrent 5-FU and Cisplatin | Experimental | Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy. Receives: Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
Measured: at 2 yrs from start of study
Secondary outcomes (41)
Patterns of Failure
Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
Measured: 2 years from start of study
Overall Survival
Number of patients still alive from 2 years from start of study
Measured: 2 yrs from start of study
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
Measured: at 12 weeks after completing chemoradiotherapy
Number of Patients With a Pathological(Final)Complete Response
A Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.
Measured: at 12 weeks after completing chemoradiotherapy and surgery
Disease Recurrence
Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.
Measured: 2 years after start of study
Number of Patients That Required a Feeding Tube
Measured: 12 weeks (after treatment)
Number of Patients That Required a Feeding Tube
Measured: 8 months after start of treatment
Number of Patients That Required a Feeding Tube
Measured: 12 months after start of treatment
Number of Patients That Required a Feeding Tube
Measured: 24 months after start of treatment
Nausea Level
Quality of life questionnaire asking "I have nausea".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4).
N (number of patients analyzed) is based on number of patients who completed the question.
Measured: 12 weeks (after treatment)
Nausea Level
Quality of life questionnaire asking "I have nausea".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months from start of treatment
Nausea Level
Quality of life questionnaire asking "I have nausea".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months from start of treatment
Nausea Level
Quality of life questionnaire asking "I have nausea".
Measured: 24 months from start of treatment
Dry Mouth
Quality of life questionnaire asking "My mouth is dry".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Dry Mouth
Quality of life questionnaire asking "My mouth is dry".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months from start of treatment
Dry Mouth
Quality of life questionnaire asking "My mouth is dry".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months from start of treatment
Dry Mouth
Quality of life questionnaire asking "My mouth is dry".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months from start of treatment
Pain
Quality of life questionnaire asking "I have pain in my mouth, throat or neck".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Pain
Quality of life questionnaire asking "I have pain in my mouth, throat or neck".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months from start of treatment
Pain
Quality of life questionnaire asking "I have pain in my mouth, throat or neck".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months from start of treatment
Pain
Quality of life questionnaire asking "I have pain in my mouth, throat or neck".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months from start of treatment
Quality of Life
Quality of life questionnaire asking "I am content with the quality of my life right now".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Quality of Life
Quality of life questionnaire asking "I am content with the quality of my life right now".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months from start of treatment
Quality of Life
Quality of life questionnaire asking "I am content with the quality of my life right now".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months from start of treatment
Quality of Life
Quality of life questionnaire asking "I am content with the quality of my life right now".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months from start of treatment
Eating
Quality of life questionnaire asking "I am able to eat the foods i like".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Eating
Quality of life questionnaire asking "I am able to eat the foods i like".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months from start of treatment
Eating
Quality of life questionnaire asking "I am able to eat the foods i like".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months from start of treatment
Eating
Quality of life questionnaire asking "I am able to eat the foods i like".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months from start of treatment
Swallowing
Quality of life questionnaire asking "I can swallow naturally and easily".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Swallowing
Quality of life questionnaire asking "I can swallow naturally and easily".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months after start of treatment
Swallowing
Quality of life questionnaire asking "I can swallow naturally and easily".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months after start of treatment
Swallowing
Quality of life questionnaire asking "I can swallow naturally and easily".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months after start of treatment
Alcohol Consumption
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Alcohol Consumption
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months after start of treatment
Alcohol Consumption
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months after start of treatment
Alcohol Consumption
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months after start of treatment
Solid Foods
Quality of life questionnaire asking "I can eat solid foods".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 weeks (after treatment)
Solid Foods
Quality of life questionnaire asking "I can eat solid foods".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 8 months after start of treatment
Solid Foods
Quality of life questionnaire asking "I can eat solid foods".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 12 months after start of treatment
Solid Foods
Quality of life questionnaire asking "I can eat solid foods".
The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Measured: 24 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2012
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J. Adelstein, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterPanayiotis Savvides, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608205
- Sponsor's protocol ID
- CASE3307
- Other IDs
- NCI-2010-01197
- Status last verified
- Jul 2020
- First submitted
- 30 Jan 2008
- Last updated
- 6 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Comparing Single Agent Cisplatin With the Combination of 5-Fluorouracil and Cisplatin, Concurrent With Radiation Therapy in Stage III and IV Squamous Cell Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00608205
- Acronym / sponsor ID
- CASE3307
- Conditions
- Head and Neck Cancer
- Keywords
- stage III squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the larynx
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Posted 19 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cisplatin and fluorouracil may kill more tumor cells. It is not yet known whether radiation therapy and cisplatin are more effective with or without fluorouracil in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy and cisplatin to compare how well they work with or without fluorouracil in treating patients with stage III or stage IV head and neck cancer.
Detailed description
OBJECTIVES:
- To compare the relapse-free survival of patients treated with radiotherapy and cisplatin with vs without fluorouracil.
- To compare the overall survival, local control without surgery, and patterns of failure in patients treated with these regimens.
- To compare the acute and long-term toxicity of these regimens in these patients.
- To compare the quality of life of patients treated with these regimens.
- To prospectively collect biopsy material, mucosal scrapings, and serum in an effort to generate hypotheses for future correlative studies.
OUTLINE: This is a multicenter study. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
- Arm II: Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy.
Patients complete questionnaires periodically to assess late toxicity and quality of life.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Radiation with concurrent Cisplatin | Active comparator | Drug: cisplatin, Radiation: radiation therapyPatients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. |
| Arm B: Radiation with concurrent 5-FU and Cisplatin | Experimental | Drug: cisplatin, Drug: fluorouracil, Radiation: radiation therapyPatients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: CDDPGiven IV | Drug | Arm A: Radiation with concurrent Cisplatin, Arm B: Radiation with concurrent 5-FU and Cisplatin |
| fluorouracilGiven IV | Drug | Arm B: Radiation with concurrent 5-FU and Cisplatin |
| radiation therapyAlso: radiationPatients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks | Radiation | Arm A: Radiation with concurrent Cisplatin, Arm B: Radiation with concurrent 5-FU and Cisplatin |
Primary outcome
Relapse Free Survival
Time frame: at 2 yrs from start of study
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
41 secondary outcomes
Patterns of Failure
Time frame: 2 years from start of study
Overall Survival
Time frame: 2 yrs from start of study
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
Time frame: at 12 weeks after completing chemoradiotherapy
Number of Patients With a Pathological(Final)Complete Response
Time frame: at 12 weeks after completing chemoradiotherapy and surgery
Disease Recurrence
Time frame: 2 years after start of study
Number of Patients That Required a Feeding Tube
Time frame: 12 weeks (after treatment)
Number of Patients That Required a Feeding Tube
Time frame: 8 months after start of treatment
Number of Patients That Required a Feeding Tube
Time frame: 12 months after start of treatment
Number of Patients That Required a Feeding Tube
Time frame: 24 months after start of treatment
Nausea Level
Time frame: 12 weeks (after treatment)
Nausea Level
Time frame: 8 months from start of treatment
Nausea Level
Time frame: 12 months from start of treatment
Nausea Level
Time frame: 24 months from start of treatment
Dry Mouth
Time frame: 12 weeks (after treatment)
Dry Mouth
Time frame: 8 months from start of treatment
Dry Mouth
Time frame: 12 months from start of treatment
Dry Mouth
Time frame: 24 months from start of treatment
Pain
Time frame: 12 weeks (after treatment)
Pain
Time frame: 8 months from start of treatment
Pain
Time frame: 12 months from start of treatment
Pain
Time frame: 24 months from start of treatment
Quality of Life
Time frame: 12 weeks (after treatment)
Quality of Life
Time frame: 8 months from start of treatment
Quality of Life
Time frame: 12 months from start of treatment
Quality of Life
Time frame: 24 months from start of treatment
Eating
Time frame: 12 weeks (after treatment)
Eating
Time frame: 8 months from start of treatment
Eating
Time frame: 12 months from start of treatment
Eating
Time frame: 24 months from start of treatment
Swallowing
Time frame: 12 weeks (after treatment)
Swallowing
Time frame: 8 months after start of treatment
Swallowing
Time frame: 12 months after start of treatment
Swallowing
Time frame: 24 months after start of treatment
Alcohol Consumption
Time frame: 12 weeks (after treatment)
Alcohol Consumption
Time frame: 8 months after start of treatment
Alcohol Consumption
Time frame: 12 months after start of treatment
Alcohol Consumption
Time frame: 24 months after start of treatment
Solid Foods
Time frame: 12 weeks (after treatment)
Solid Foods
Time frame: 8 months after start of treatment
Solid Foods
Time frame: 12 months after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David J. Adelstein, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Panayiotis Savvides, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cisplatin, fluorouracil and radiation therapy in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 2 sites 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?
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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Relapse Free Survival (time frame: at 2 yrs from start of study). 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 6 Aug 2020.