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

Phase 2

Completed

• Conditions: Nasopharyngeal Cancer
• Interventions: Radiation: Radiotherapy; Drug: Cisplatin; Drug: 5-FU

• Registration Number: NCT03175939
• Lead Sponsor: Sun Yat-sen University

Brief 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)

Study Timeline

• Study Start: 1998-04-01
• Primary Completion: 2008-12-31
• Study Completion: 2014-12-31
• Study First Submitted: 2017-05-31
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-02
• Last Update Submitted: 2017-06-02
• Study First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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),

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCRT alone	Radiotherapy	External beam radiotherapy \> 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
CCRT alone	Cisplatin	External beam radiotherapy \> 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
CCRT alone	5-FU	External beam radiotherapy \> 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy

Primary Outcome Measures

Name	Time	Method
Distant-metastasis-free survival	5 years	percentage of patients who survived and has no distant metastasis

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	percentage of patients who survived
disease-free survival	5 years	percentage of patients who survived and had no disease recurrence