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

July 19, 2008
August 23, 2013
September 2007
August 2012   (final data collection date for primary outcome measure)
  • Overall survival at 2 years [ Designated as safety issue: No ]
  • Health economics using quality adjusted life years [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00720070 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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 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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Diagnostic
Head and Neck Cancer
  • Procedure: positron emission tomography/computed tomography
    Patients undergo PET/CT scan
  • Procedure: therapeutic conventional surgery
    Patients undergo neck dissection
  • 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.
    Interventions:
    • Procedure: positron emission tomography/computed tomography
    • Procedure: therapeutic conventional surgery
  • 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.
    Interventions:
    • Procedure: positron emission tomography/computed tomography
    • Procedure: therapeutic conventional surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
Not Provided
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United Kingdom
 
NCT00720070
CDR0000597895, WMS-PET-NECK, ISRCTN13735240, EU-20856, MREC-07/Q1604/35, UKCRN ID: 3799
Not Provided
Not Provided
Warwick Medical School
Not Provided
Principal Investigator: Hisham Mehanna, MD Warwick Medical School
National Cancer Institute (NCI)
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP