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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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England
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Coventry, England, Vereinigtes Königreich, CV4 7AL
- Rekrutierung
- Warwick Medical School Clinical Trials Unit
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Kontakt:
- Hisham Mehanna, MD
- Telefonnummer: 44-247-696-5606
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
Patients undergo PET/CT scan
Patients undergo neck dissection
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Aktiver Komparator: Arm II
Patients undergo neck dissection and receive standard concurrent CRT.
Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
|
Patients undergo PET/CT scan
Patients undergo neck dissection
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
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Gesamtüberleben nach 2 Jahren
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Health economics using quality adjusted life years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
|---|
|
Lebensqualität
|
|
Komplikationsraten
|
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Krankheitsspezifisches Überleben
|
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Recurrence and local control in neck
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Utility cost
|
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Accuracy of PET-CT scanning for assessing primary tumor
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hisham Mehanna, MD, Warwick Medical School
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Plattenepithelkarzinom im Stadium III der Lippe und Mundhöhle
- verruköses Karzinom der Mundhöhle im Stadium III
- Plattenepithelkarzinom des Oropharynx im Stadium III
- Plattenepithelkarzinom im Stadium III des Hypopharynx
- Plattenepithelkarzinom des Kehlkopfes im Stadium III
- Stadium III verruköses Karzinom des Kehlkopfes
- Plattenepithelkarzinom im Stadium I der Lippen- und Mundhöhle
- Plattenepithelkarzinom der Lippe und Mundhöhle im Stadium II
- Plattenepithelkarzinom des Hypopharynx im Stadium I
- Plattenepithelkarzinom des Kehlkopfes im Stadium I
- Plattenepithelkarzinom im Stadium I des Oropharynx
- Stadium II Plattenepithelkarzinom des Hypopharynx
- Plattenepithelkarzinom des Kehlkopfes im Stadium II
- Plattenepithelkarzinom im Stadium II des Oropharynx
- Zungenkrebs
- verruköses Karzinom der Mundhöhle im Stadium I
- Stadium II verruköses Karzinom der Mundhöhle
- verruköses Karzinom des Kehlkopfes im Stadium I
- Stadium II verruköses Karzinom des Kehlkopfes
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CDR0000597895
- WMS-PET-NECK
- ISRCTN13735240
- EU-20856
- MREC-07/Q1604/35
- UKCRN ID: 3799
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