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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00720070
First received: July 19, 2008
Last updated: August 23, 2013
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Procedure: positron emission tomography/computed tomography
Procedure: therapeutic conventional surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 2 years [ Designated as safety issue: No ]
  • Health economics using quality adjusted life years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-specific survival [ Designated as safety issue: No ]
  • Recurrence and local control in neck [ Designated as safety issue: No ]
  • Utility cost [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Complication rates [ Designated as safety issue: Yes ]
  • Accuracy of PET-CT scanning for assessing primary tumor [ Designated as safety issue: No ]

Estimated Enrollment: 560
Study Start Date: September 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: positron emission tomography/computed tomography
Patients undergo PET/CT scan
Procedure: therapeutic conventional surgery
Patients undergo neck dissection
Active Comparator: Arm II
Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
Procedure: positron emission tomography/computed tomography
Patients undergo PET/CT scan
Procedure: therapeutic conventional surgery
Patients undergo neck dissection

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720070

Locations
United Kingdom
Warwick Medical School Clinical Trials Unit Recruiting
Coventry, England, United Kingdom, CV4 7AL
Contact: Hisham Mehanna, MD    44-247-696-5606      
Sponsors and Collaborators
Warwick Medical School
Investigators
Principal Investigator: Hisham Mehanna, MD Warwick Medical School
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00720070     History of Changes
Other Study ID Numbers: CDR0000597895, WMS-PET-NECK, ISRCTN13735240, EU-20856, MREC-07/Q1604/35, UKCRN ID: 3799
Study First Received: July 19, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014