NCT03138642

Mucosal Melanoma of Head and Neck in Intensity-modulated Radiotherapy Era

Status unknown Phase 2 Last updated 30 January 2018

What this trial tests

Phase 2 trial testing RT in Mucosal Melanoma in 30 participants. Status unknown.

Timeline

1 July 2010

Primary endpoint
30 May 2017

30 May 2020

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 July 2010
Primary completion	30 May 2017
Estimated completion	30 May 2020
Sites	1 location across China

Drugs / interventions tested

• RT

Conditions studied

• Mucosal Melanoma — all drugs for Mucosal Melanoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Mucosal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In China, mucosal melanoma of head and neck (MMHN) account for 30-40% of all melanoma and the incidence is on the rise. The prognosis of MMHN is poor with the 5-year survival in a range between 20-30%. The evidence for the treatment of MMHN was weak since large-sample clinical researches are rare and no prospective clinical trial is reported. Surgery is the primary treatment modality for MMHN. However, it is difficult to extend the necessary surgery range for MMHN due to its limitation of being adjacent to the important anatomical structure in head and neck or by the considerations of the protection for organ function. As a result, the recurrence rate for surgery along was over 50%. Radiotherapy(RT) is the main approach for the multidisciplinary treatment for MMHN. Benlyazid et al. conclude the data from 13 centers and find that compared to surgery alone, the addition of post-surgery RT improve the survival; The 5-year locoregional failure rate for the surgery alone group and the RT+surgery group were 55.6% and 29.9%, respectively. Currently, the research into the prognosis factors is spare for the non-metastatic MMMHN received extended resection to primary tumor. It is necessary to undertake a prospective clinical research for MMHN in the endemic area to estimate efficacy and safety of primary surgery plus postoperative radiotherapy with or without adjuvant chemotherapy, as well as to recognize the risk distribution in this cohort of patients, provide the evidence to improve the stratification treatment strategies in the clinic.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging strategies to treat rare and intractable subtypes of melanoma.
   Alicea GM, Rebecca VW. · · 2021 · cited 30× · PMID 32274887 · DOI 10.1111/pcmr.12880
2. Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study.
   Yao JJ, Zhang F, Zhang GS, Deng XW, et al · · 2018 · cited 10× · PMID 30588103 · DOI 10.2147/cmar.s185017