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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03175939

Enrollment

263

Registered

2017-06-05

Start date

1998-04-01

Completion date

2014-12-31

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Cancer

Keywords

adjuvant chemotherapy, NPC

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)

Interventions

RADIATIONRadiotherapy

External beam radiotherapy with curative intent, at least 66 Gy

DRUGCisplatin

cisplatin IV injection over 3 hours

DRUG5-FU

5-FU IV 24 hours continuous infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Distant-metastasis-free survival	5 years	percentage of patients who survived and has no distant metastasis

Secondary

Measure	Time frame	Description
overall survival	5 years	percentage of patients who survived
disease-free survival	5 years	percentage of patients who survived and had no disease recurrence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026