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

Nasopharyngeal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175939
• Other study ID #: NPC9801
• Status: Completed
• Phase: Phase 2
• First received: May 31, 2017
• Last updated: June 2, 2017
• Start date: April 1, 1998
• Est. completion date: December 31, 2014

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: December 31, 2014
• Est. primary completion date: December 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) biopsy-proven carcinoma of the nasopharynx,

• (2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,

• (3) normal renal function (Cr < 1.6 mg/dl),

Exclusion Criteria:

• open-neck lymph node biopsy

• previous chemotherapy or radiotherapy to the head and neck region

• distant metastasis or other malignant diseases except skin cancer

Related Conditions & MeSH terms

• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• Radiotherapy
External beam radiotherapy with curative intent, at least 66 Gy

Drug:
• Cisplatin
cisplatin IV injection over 3 hours
• 5-FU
5-FU IV 24 hours continuous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distant-metastasis-free survival	percentage of patients who survived and has no distant metastasis	5 years
Secondary	overall survival	percentage of patients who survived	5 years
Secondary	disease-free survival	percentage of patients who survived and had no disease recurrence	5 years