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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Brief Summary

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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

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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

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Head and Neck Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Study Groups

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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.

Group Type EXPERIMENTAL

positron emission tomography/computed tomography

Intervention Type PROCEDURE

Patients undergo PET/CT scan

therapeutic conventional surgery

Intervention Type PROCEDURE

Patients undergo neck dissection

Arm II

Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.

Group Type ACTIVE_COMPARATOR

positron emission tomography/computed tomography

Intervention Type PROCEDURE

Patients undergo PET/CT scan

therapeutic conventional surgery

Intervention Type PROCEDURE

Patients undergo neck dissection

Interventions

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positron emission tomography/computed tomography

Patients undergo PET/CT scan

Intervention Type PROCEDURE

therapeutic conventional surgery

Patients undergo neck dissection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Hisham Mehanna, MD

Role: PRINCIPAL_INVESTIGATOR

Warwick Medical School

Locations

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Warwick Medical School Clinical Trials Unit

Coventry, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Hisham Mehanna, MD

Role: primary