Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| positron emission tomography/computed tomography | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Procedure: positron emission tomography/computed tomography
- Procedure: therapeutic conventional surgery
- type
- ACTIVE_COMPARATOR
- label
- Arm II
- description
- Patients undergo neck dissection and receive standard concurrent CRT. Patients undergo PET/CT scan at 9-13 weeks after completion of CRT.
- interventionNames
- Procedure: positron emission tomography/computed tomography
- Procedure: therapeutic conventional surgery
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available