NCT03175939

Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

Detailed description

The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Conditions

• Nasopharyngeal Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	External beam radiotherapy with curative intent, at least 66 Gy
DRUG	Cisplatin	cisplatin IV injection over 3 hours
DRUG	5-FU	5-FU IV 24 hours continuous infusion

Timeline

• Start date: 1998-04-01
• Primary completion: 2008-12-31
• Completion: 2014-12-31
• First posted: 2017-06-05
• Last updated: 2017-06-05