Carcinoma of Unknown Primary, Head-and-neck Cancer
Conditions
Brief summary
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.
Interventions
RADIATIONElective mucosal irradiaton
Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.
Sponsors
Shanghai Jiao Tong University School of Medicine
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal recurrence free survival | 3 years | from date of enrollment to date of first documented primary site emergence or death, assessed up to 3 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3 years | from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 3 years. |
| Neck control rate | 3 years | from date of enrollment until date of first documented neck relapse, assessed up to 3 years. |
| overall survival rate | 3 years | from date of enrollment until date of first death from any cause, assessed up to 3 years. |
| Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) | 2 months | Acute toxicities(gastrointestinal toxicities,hematologic toxicities, dysphagia,oral mucositis) during the course of radiotherapy |
Countries
China
Contacts
Primary ContactGuopei Zhu, M.D.
Outcome results
None listed