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Elective Mucosal Irradiation in Head-and-Neck Cancer of Unknown Primary

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status and phase

Unknown
Phase 2

Conditions

Carcinoma of Unknown Primary
Head-and-neck Cancer

Treatments

Radiation: Elective mucosal irradiaton

Study type

Interventional

Funder types

Other

Identifiers

NCT02764216
1501160-4

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

EMI group
Experimental group
Description:
Elective mucosal irradiation
Treatment:
Radiation: Elective mucosal irradiaton

Trial contacts and locations

2

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Central trial contact

Guopei Zhu, M.D.

Data sourced from clinicaltrials.gov

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