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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03175939
Other study ID # NPC9801
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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