Head and Neck CancerPhase 3NCT00720070
PET/CT Scan-Guided Watchful Waiting or Neck Dissection of Locally Advanced Lymph Node Metastases in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Primary Head And Neck Cancer
A Phase 3 study testing positron emission tomography/computed tomography and therapeutic conventional surgery in people with Head and Neck Cancer, run by Warwick Medical School at 1 site in United Kingdom.
Trial summary
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body and may help doctors detect residual disease and plan the best treatment. Neck dissection is surgery to remove lymph nodes and other tissues in the neck. 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?
- positron emission tomography/computed tomography and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Aug 2012
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed head and neck squamous cell carcinoma (HNSCC), including any of the following subtypes:
- Oropharyngeal
- Laryngeal
- Oral
- Hypopharyngeal
- No primary nasopharyngeal carcinoma
- Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or N3
- No occult nodal metastasis (i.e., large nodal metastasis but no proven primary site on clinical assessment)
- No N1 nodal metastasis
- Planning to receive curative radical concurrent chemoradiotherapy (approved by study) for primary disease
- Patients undergoing neoadjuvant chemotherapy followed by concurrent chemoradiotherapy are eligible
- Able to undergo neck dissection surgery
- No current resection for primary tumor planned (e.g., resection of tonsil or base of tongue with flap reconstruction [diagnostic tonsillectomy allowed])
- No distant metastases to chest, liver, bones, or other sites
PATIENT CHARACTERISTICS:
- Not pregnant
- No other cancer diagnosis within the past 5 years except basal cell carcinoma or cervical carcinoma in situ
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for HNSCC
- No concurrent neoadjuvant chemoradiotherapy without concurrent chemotherapy
- No concurrent adjuvant chemotherapy
- No concurrent chemoradiotherapy for palliative purposes
- No concurrent radiotherapy alone
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Warwick Medical School Clinical Trials Unit
Coventry, England, CV4 7AL
Hisham Mehanna, MD, 44-247-696-5606
About this study
Official title: A Multi-centre Randomised Phase III Trial Comparing PET-CT Guided Watch and Wait Policy Versus Planned Neck Dissection for the Management of Locally Advanced (N2/N3) Nodal Metastases in Patients With Head and Neck Squamous Cancer
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body and may help doctors detect residual disease and plan the best treatment. Neck dissection is surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a neck dissection should always be performed in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting compared with neck dissection of locally advanced lymph node metastases in treating patients who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.
Read the detailed description
OBJECTIVES:
- To compare the efficacy, in terms of overall survival, disease-specific survival, recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and wait policy with the current practice of planned neck dissection in the management of advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous cell carcinoma undergoing chemoradiotherapy.
- To assess the predictive value of PET/CT scanning in detecting persistent or residual disease in the primary site.
OUTLINE: This is a multicenter study. Patients are stratified according to center, chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks.
- Arm II: Patients undergo neck dissection and then receive standard CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Patients are assessed periodically for quality-of-life. Tissue and blood samples collected periodically are stored for future research.
After completion of study treatment, patients are followed monthly for 1 year and then bimonthly for 1 year.
- Conditions
- Head and Neck Cancer
- Being tested
- positron emission tomography/computed tomography, therapeutic conventional surgery
- Keywords
- stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I verrucous carcinoma of the oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage II verrucous carcinoma of the oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage III verrucous carcinoma of the oral cavity, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, tongue cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Tongue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomography/computed tomographyProcedure or surgery
Patients undergo PET/CT scan
therapeutic conventional surgeryProcedure or surgery
Patients undergo neck dissection
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks. Receives: Procedure: positron emission tomography/computed tomography; Procedure: therapeutic conventional surgery |
| Arm II | Active comparator | Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Receives: Procedure: positron emission tomography/computed tomography; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival at 2 years
Health economics using quality adjusted life years
Secondary outcomes (6)
Disease-specific survival
Recurrence and local control in neck
Utility cost
Quality of life
Complication rates
Accuracy of PET-CT scanning for assessing primary tumor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Warwick Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Hisham Mehanna, MD, Principal investigator, Warwick Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720070
- Sponsor's protocol ID
- CDR0000597895
- Other IDs
- WMS-PET-NECK, ISRCTN13735240, EU-20856, MREC-07/Q1604/35, UKCRN ID: 3799
- Status last verified
- Dec 2008
- First submitted
- 19 Jul 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomised Phase III Trial Comparing PET-CT Guided Watch and Wait Policy Versus Planned Neck Dissection for the Management of Locally Advanced (N2/N3) Nodal Metastases in Patients With Head and Neck Squamous Cancer
- ClinicalTrials.gov ID
- NCT00720070
- Acronym / sponsor ID
- CDR0000597895
- Conditions
- Head and Neck Cancer
- Keywords
- stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the larynx, stage I verrucous carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage II verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the larynx
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Warwick Medical SchoolUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Aug 2012 (estimated)
- First posted
- 22 Jul 2008 (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.
RATIONALE: Imaging procedures, such as PET/CT scan, produce pictures of areas inside the body and may help doctors detect residual disease and plan the best treatment. Neck dissection is surgery to remove lymph nodes and other tissues in the neck. It is not yet known whether a neck dissection should always be performed in treating patients with head and neck cancer.
PURPOSE: This randomized phase III trial is studying PET/CT scan-guided watchful waiting compared with neck dissection of locally advanced lymph node metastases in treating patients who are undergoing chemotherapy and radiation therapy for primary head and neck cancer.
Detailed description
OBJECTIVES:
- To compare the efficacy, in terms of overall survival, disease-specific survival, recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and wait policy with the current practice of planned neck dissection in the management of advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous cell carcinoma undergoing chemoradiotherapy.
- To assess the predictive value of PET/CT scanning in detecting persistent or residual disease in the primary site.
OUTLINE: This is a multicenter study. Patients are stratified according to center, chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks.
- Arm II: Patients undergo neck dissection and then receive standard CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Patients are assessed periodically for quality-of-life. Tissue and blood samples collected periodically are stored for future research.
After completion of study treatment, patients are followed monthly for 1 year and then bimonthly for 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: positron emission tomography/computed tomography, Procedure: therapeutic conventional surgeryPatients receive standard concurrent chemoradiotherapy (CRT). Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of primary site undergo neck dissection within 4 weeks. |
| Arm II | Active comparator | Procedure: positron emission tomography/computed tomography, Procedure: therapeutic conventional surgeryPatients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT. |
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 |
|---|---|---|
| positron emission tomography/computed tomographyPatients undergo PET/CT scan | Procedure or surgery | Arm I, Arm II |
| therapeutic conventional surgeryPatients undergo neck dissection | Procedure or surgery | Arm I, Arm II |
Primary outcome
Overall survival at 2 years
Health economics using quality adjusted life years
6 secondary outcomes
Disease-specific survival
Recurrence and local control in neck
Utility cost
Quality of life
Complication rates
Accuracy of PET-CT scanning for assessing primary tumor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Hisham Mehanna, MD principal investigator
Warwick Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing positron emission tomography/computed tomography and therapeutic conventional surgery in people with Head and Neck Cancer, run by Warwick Medical School at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 2 years. 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 26 Aug 2013.