Cancer of the PharynxPhase 3DeCIDENCT00117572
Docetaxel Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DeCIDE)
A Phase 3 study testing docetaxel, cisplatin and hydroxyurea in people with Cancer of the Pharynx and Cancer of the Larynx, run by University of Chicago at 26 sites in 5 countries.
Trial summary
The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity
- What is being tested?
- docetaxel, cisplatin and hydroxyurea
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 26 sitesin 5 countries
- Study dates
- Nov 2004to Dec 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
Who may be able to join
- Age 18 years or older
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma
- No prior chemotherapy or radiotherapy
- Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor
- Karnofsky performance status of >= 70%
- Intact organ and bone marrow function
- Obtained informed consent
Who cannot join
- Demonstration of metastatic disease (i.e. M1 disease).
- Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea
- Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years.
- Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment.
- Incomplete healing from previous surgery
- Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
Show all 9Show fewer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.
- Uncontrolled active infection unless curable with treatment of their cancer.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United States20 sites
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
The University of Chicago
Chicago, Illinois, 60637
Weiss Memorial Hospital
Chicago, Illinois, 60640
Henry Ford Health System
Detroit, Michigan, 48202
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Roger Maris Cancer Center
Fargo, North Dakota, 58122
Fort Wayne Medical Oncology/Hematology Inc.
Fort Wayne, Indiana, 46815
Joliet Oncology Hematology Associates
Joliet, Illinois, 60435
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Kansas City VA Medical Center
Kansas City, Missouri, 64128
USC University of Southern California Keck School of Medicine
Los Angeles, California, 90033
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104
UM Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Oncology Alliance
Milwaukee, Wisconsin, 53215
University of Minnesota
Minneapolis, Minnesota, 55455
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085
UT Health Science Center at San Antonio
San Antonio, Texas, 78258
AP&S Clinic, LLC
Terre Haute, Indiana, 47807
Croatia2 sites
Clinic of Oncology, University Hospital Center Zagreb
Zagreb, 10000
University Hospital for Tumors Zagreb
Zagreb, 10000
Russia2 sites
NN Blokhin Russian Cancer Research Centre RAMS
Moscow
Republican Oncology Dispensary
Ufa
About this study
Official title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer
The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.
Read the detailed description
TRIAL DESIGN:
Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer
OBJECTIVES:
Primary
- To determine the effect on overall survival when induction chemotherapy is administered prior to chemoradiotherapy in patients with N2 or N3 disease.
Secondary
- To determine the effect of induction chemotherapy when administered prior to chemoradiotherapy on distant failure-free survival, failure pattern, progression free survival and quality of life.
TREATMENT PLAN:
- After eligibility is confirmed, patients will be randomized to one of two treatment arms:
Arm A - Induction + chemoradiotherapy
Arm B - Chemoradiotherapy alone
- Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (day 1), cisplatin (day 1), and 5-fluorouracil (days 1-5). Total duration of 6 weeks.
- Chemoradiotherapy: Five 14-day cycles of docetaxel (day 1), 5-fluorouracil (day 0-4), and hydroxyurea (days 0-4) with twice daily radiation (days 1-5). Total duration of 10 weeks.
- All patients will undergo surgical evaluation after chemoradiation for possible neck dissection.
- Upon completion of treatment, patients will be monitored every three months during the first year, every six months during the second and third years, and annually thereafter, up to seven years.
- Patients will be followed for Quality of Life (QOL) during the course of treatment, as well as annually thereafter, up to five years.
PROJECTED ACCRUAL:
- An expected sample size of 400 patients will be enrolled for this study (200 per treatment arm).
- Conditions
- Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity
- Being tested
- docetaxel, cisplatin, hydroxyurea, fluorouracil, chemotherapy
- Keywords
- Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx), Cancer of the Nasal Cavity and Paranasal Sinuses
- Medical subject headings
- Pharyngeal Neoplasms, Laryngeal Neoplasms, Paranasal Sinus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase)
cisplatinDrug
75 mg/m2 on day 1
hydroxyureaDrug
Each cycle: 500 mg PO q 12 hours x 6 days (11 doses)
fluorouracilDrug
750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase)
chemotherapyProcedure or surgery
See protocol for details
radiotherapyProcedure or surgery
See protocol for details
| Study group | Role | What they receive |
|---|---|---|
| Induction plus chemoradiotherapy | Active comparator | Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks.
Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. Receives: Drug: docetaxel; Drug: cisplatin; Drug: hydroxyurea; Drug: fluorouracil; Procedure: chemotherapy; Procedure: radiotherapy |
| Chemoradiotherapy | Active comparator | Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. Receives: Drug: docetaxel; Drug: hydroxyurea; Drug: fluorouracil; Procedure: chemotherapy; Procedure: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival: Time From Randomization to Death From Any Cause
Survival rates over 6 years.
Measured: Up to 6 years
Secondary outcomes (12)
Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
DFFS rates over 6 years. DFFS is time from randomization to distant recurrence or death from any cause
Measured: Up to 6 years
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
Recurrence-free survival rates over 6 years. Recurrence-free survival is time from randomization to local, regional, or distant recurrence or death from any cause
Measured: Up to 6 years
Failure Pattern (Local/Regional Recurrence)
Percentage of patients with local/regional recurrence
Measured: Up to 6 years
Failure Pattern (Distant Recurrence)
Percentage of patients with distant recurrence
Measured: Up to 6 years
Quality of Life (FACT H&N)
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (Normalcy of Diet)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (Speech)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (McMaster)
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (FACT H&N)
FACT Hand-and-neck subscale(b) (0-40 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to 1 year (1 year-pre)
Quality of Life (Normalcy of Diet)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to 1 year (1 year-pre)
Quality of Life (Speech)
Performance Status Score (0-100 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to 1 year (1 year-pre)
Quality of Life (McMaster)
McMaster RT Questionnaire (4-28 point scale with negative numbers indicating worsening of function)
Measured: Change from baseline to 1 year (1 year-pre)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2016
- Study completionDec 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 Cancer of the PharynxStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett Vokes, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117572
- Sponsor's protocol ID
- 13362B
- Acronym
- DeCIDE
- Status last verified
- Apr 2018
- First submitted
- 30 Jun 2005
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00117572
- Acronym / sponsor ID
- DeCIDE / 13362B
- Conditions
- Cancer of the Pharynx, Cancer of the Larynx, Cancer of the Nasal Cavity, Paranasal Sinus Neoplasms, Cancer of the Oral Cavity
- Keywords
- Cancer of the Pharynx (Nasopharynx, Oropharynx, Hypopharynx), Cancer of the Nasal Cavity and Paranasal Sinuses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Jul 2005 (estimated)
- Results
- Posted 9 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.
Detailed description
TRIAL DESIGN:
Phase III trial of induction therapy with docetaxel followed by chemoradiotherapy versus chemoradiotherapy alone in patients with nodal stage N2 or N3 head and neck cancer
OBJECTIVES:
Primary
- To determine the effect on overall survival when induction chemotherapy is administered prior to chemoradiotherapy in patients with N2 or N3 disease.
Secondary
- To determine the effect of induction chemotherapy when administered prior to chemoradiotherapy on distant failure-free survival, failure pattern, progression free survival and quality of life.
TREATMENT PLAN:
- After eligibility is confirmed, patients will be randomized to one of two treatment arms:
Arm A - Induction + chemoradiotherapy
Arm B - Chemoradiotherapy alone
- Induction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (day 1), cisplatin (day 1), and 5-fluorouracil (days 1-5). Total duration of 6 weeks.
- Chemoradiotherapy: Five 14-day cycles of docetaxel (day 1), 5-fluorouracil (day 0-4), and hydroxyurea (days 0-4) with twice daily radiation (days 1-5). Total duration of 10 weeks.
- All patients will undergo surgical evaluation after chemoradiation for possible neck dissection.
- Upon completion of treatment, patients will be monitored every three months during the first year, every six months during the second and third years, and annually thereafter, up to seven years.
- Patients will be followed for Quality of Life (QOL) during the course of treatment, as well as annually thereafter, up to five years.
PROJECTED ACCRUAL:
- An expected sample size of 400 patients will be enrolled for this study (200 per treatment arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction plus chemoradiotherapy | Active comparator | Drug: docetaxel, Drug: cisplatin, Drug: hydroxyurea, Drug: fluorouracil, Procedure: chemotherapy, Procedure: radiotherapyInduction therapy: Two 21-day cycles of chemotherapy consisting of docetaxel (75 mg/m2, day 1), cisplatin (75 mg/m2, day 1), and 5-fluorouracil (750 mg/m2/day, days 1-5). Total duration of 6 weeks. Chemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. |
| Chemoradiotherapy | Active comparator | Drug: docetaxel, Drug: hydroxyurea, Drug: fluorouracil, Procedure: chemotherapy, Procedure: radiotherapyChemoradiotherapy: Five 14-day cycles of docetaxel (25 mg/m2, day 1), 5-fluorouracil (600 mg/m2/day, day 0-4), and hydroxyurea (500 mg PO q 12 hours x 6 days (11 doses)) with twice daily radiation (150 cGy given bid, days 1-5). Total duration of 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck (excluding lip), or lymphoepithelioma
- No prior chemotherapy or radiotherapy
- Prior surgical therapy will consist only of incisional or excisional biopsy, and organ sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an existing primary tumor
- Karnofsky performance status of >= 70%
Key exclusion criteria (9 listed)
- Demonstration of metastatic disease (i.e. M1 disease).
- Patients with a history of severe allergic reaction to docetaxel or other drugs formulated with polysorbate 80. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, 5-fluorouracil, or hydroxyurea
- Other coexisting malignancies or malignancies diagnosed within the previous 3 years with the exception of basal cell carcinoma, cervical cancer in situ, and other treated malignancies with no evidence of disease for at least 3 years.
- Prior surgical therapy other than incisional or excisional biopsy and organ-sparing procedures such as debulking of airway-compromising tumors or neck dissection in a patient with an unknown primary tumor. Any non-biopsy procedure must have taken place less than 3 months from initiating protocol treatment.
- Incomplete healing from previous surgery
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 |
|---|---|---|
| docetaxel75 mg/m2 on day 1 (induction phase); 25 mg/m2 on day 1 (chemoradiotherapy phase) | Drug | Chemoradiotherapy, Induction plus chemoradiotherapy |
| cisplatin75 mg/m2 on day 1 | Drug | Induction plus chemoradiotherapy |
| hydroxyureaEach cycle: 500 mg PO q 12 hours x 6 days (11 doses) | Drug | Chemoradiotherapy, Induction plus chemoradiotherapy |
| fluorouracil750 mg/m2/day on days 1-5 (induction phase); 600 mg/m2/day, day 0-4 (chemoradiotherapy phase) | Drug | Chemoradiotherapy, Induction plus chemoradiotherapy |
| chemotherapySee protocol for details | Procedure or surgery | Chemoradiotherapy, Induction plus chemoradiotherapy |
| radiotherapySee protocol for details | Procedure or surgery | Chemoradiotherapy, Induction plus chemoradiotherapy |
Primary outcome
Overall Survival: Time From Randomization to Death From Any Cause
Time frame: Up to 6 years
Survival rates over 6 years.
12 secondary outcomes
Distant Failure-free Survival (DFFS): Time From Randomization to Distant Recurrence or Death From Any Cause
Time frame: Up to 6 years
Recurrence Free Survival: Time From Randomization to Local/Regional/Distant Recurrence or Death From Any Cause
Time frame: Up to 6 years
Failure Pattern (Local/Regional Recurrence)
Time frame: Up to 6 years
Failure Pattern (Distant Recurrence)
Time frame: Up to 6 years
Quality of Life (FACT H&N)
Time frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (Normalcy of Diet)
Time frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (Speech)
Time frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (McMaster)
Time frame: Change from baseline to post-CRT (post-pre). This corresponds to week 16 in the induction arm and week 10 in the CRT alone arm.
Quality of Life (FACT H&N)
Time frame: Change from baseline to 1 year (1 year-pre)
Quality of Life (Normalcy of Diet)
Time frame: Change from baseline to 1 year (1 year-pre)
Quality of Life (Speech)
Time frame: Change from baseline to 1 year (1 year-pre)
Quality of Life (McMaster)
Time frame: Change from baseline to 1 year (1 year-pre)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cancer of the Pharynx
RecruitingPhase 2
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced 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
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Active, not recruitingPhase 2/3
Comparing Cisplatin Every Three Weeks to Cisplatin Weekly When Combined With Radiation for Patients With Advanced Head and Neck Cancer
Advanced Head and Neck Squamous Cell Carcinoma, Advanced Hypopharyngeal Squamous Cell Carcinoma
Active, not recruitingObservational study
The Clinical Application Value of CAIX-Targeted PET Hypoxia Imaging in Malignant Tumors
Nasopharyngeal Cancers, Lung Cancer (NSCLC)
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.
Everett Vokes, M.D. principal investigator
University of Chicago
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel, cisplatin and hydroxyurea in people with Cancer of the Pharynx and Cancer of the Larynx, run by University of Chicago at 26 sites in 5 countries.
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 9 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Croatia, Russia, France, Spain. 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 9 Apr 2018). 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?
Overall Survival: Time From Randomization to Death From Any Cause (time frame: Up to 6 years). 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 9 Apr 2018.