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

NCT00720070 | Unknown Phase 3

• 6 other identifiers: CDR0000597895WMS-PET-NECKISRCTN13735240EU-20856MREC-07/Q1604/35UKCRN ID: 3799
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

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.

Procedure: positron emission tomography/computed tomography; Procedure: therapeutic conventional surgery

Interventions

positron emission tomography/computed tomography PROCEDURE

Patients undergo PET/CT scan

Arm I; Arm II

therapeutic conventional surgery PROCEDURE

Patients undergo neck dissection

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Warwick Medical School: lead

Study Sites (1)

Warwick Medical School Clinical Trials Unit

Coventry, England, CV4 7AL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Hisham Mehanna, MD

  Warwick Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2008
• First Posted: July 22, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2012
• Last Updated: August 26, 2013

Record last verified: 2008-12

Locations

GB (1)