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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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England
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Coventry, England, Storbritannia, CV4 7AL
- Rekruttering
- Warwick Medical School Clinical Trials Unit
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Ta kontakt med:
- Hisham Mehanna, MD
- Telefonnummer: 44-247-696-5606
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Patients undergo PET/CT scan
Patients undergo neck dissection
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Aktiv 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.
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Patients undergo PET/CT scan
Patients undergo neck dissection
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Hva måler studien?
Primære resultatmål
Resultatmål |
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Total overlevelse ved 2 år
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Health economics using quality adjusted life years
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Sekundære resultatmål
Resultatmål |
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Livskvalitet
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Komplikasjonsrater
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Sykdomsspesifikk overlevelse
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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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Hisham Mehanna, MD, Warwick Medical School
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- stadium III plateepitelkarsinom i leppe og munnhule
- stadium III verrucous karsinom i munnhulen
- stadium III plateepitelkarsinom i orofarynx
- stadium III plateepitelkarsinom i hypopharynx
- stadium III plateepitelkarsinom i strupehodet
- stadium III verrucous karsinom i strupehodet
- stadium I plateepitelkarsinom i leppe og munnhule
- stadium II plateepitelkarsinom i leppe og munnhule
- stadium I plateepitelkarsinom i hypopharynx
- stadium I plateepitelkarsinom i strupehodet
- stadium I plateepitelkarsinom i orofarynx
- stadium II plateepitelkarsinom i hypopharynx
- stadium II plateepitelkarsinom i strupehodet
- stadium II plateepitelkarsinom i orofarynx
- tungekreft
- stadium I verrucous karsinom i munnhulen
- stadium II verrucous karsinom i munnhulen
- stadium I verrucous karsinom i strupehodet
- stadium II verrucous karsinom i strupehodet
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000597895
- WMS-PET-NECK
- ISRCTN13735240
- EU-20856
- MREC-07/Q1604/35
- UKCRN ID: 3799
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