Clinical trial · Interventional
Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary
Elective Mucosal Irradiation in Head-and Neck Cancer of Unknown Primary, A Single Arm Phase II Trial
- 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)
The optimal treatment of HNCUP remains controversial and lacks evidence from prospective randomized trials. The management of these patients relies primarily on surgery and radiotherapy. The role of radiotherapy in sterilizing putative mucosal sites remains controversial. The main debate concerns the extent of the radiation field. Although pan-mucosal irradiation from the nasopharynx to the hypopharynx and bilateral neck nodes reduces the risk of emergence of a mucosal primary or a nodal relapse, it has been associated with significant toxicity and long-term morbidity (mostly xerostomia and dysphagia). Most single institution retrospective studies have not shown any advantage for more extensive irradiation.Therefore, elective mucosal irradiation may might be appropriate only for these patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma of Unknown Primary | Carcinoma of Unknown Primary | ONTOLOGY_EXACT | 0.98 |
| Head-and-neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elective mucosal irradiaton | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EMI group
- description
- Elective mucosal irradiation
- interventionNames
- Radiation: Elective mucosal irradiaton
Primary outcomes (1)
- measure
- Mucosal recurrence free survival
- timeFrame
- 3 years
- description
- from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years.
Secondary outcomes (4)
- measure
- Disease-free survival
- timeFrame
- 3 years
- description
- from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Carcinomas metastatic to cervical lymph node with unknown primary 2. Squamous cell carcinoma, poorly differentiated carcinoma, or undifferentiated carcinoma 3. All patients must be suitable to attend regular follow-up and undergo toxicity assessment. 4. Stage T0, N1-3, M0 disease 5. Karnofsky score over 60 6. No significant cardiac, chest, gastrointestinal or renal morbidities Exclusion Criteria: 1. Previous radiotherapy to the head and neck region 2. Previous malignancy except non-melanoma skin cancer 3. Previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up
References
Publications (1)
- DERIVEDDou S, Li R, Zhang L, Wang Z, Xie L, Zhang C, Zhu G. Long-term results of elective mucosal irradiation for head and neck cancer of unknown primary in Chinese population: The EMICUP study. Cancer Med. 2020 Mar;9(5):1712-1720. doi: 10.1002/cam4.2856. Epub 2020 Jan 17. PMID 31953927