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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-01

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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

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Nasopharyngeal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCRT alone

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

Group Type EXPERIMENTAL

Radiotherapy

Intervention Type RADIATION

External beam radiotherapy with curative intent, at least 66 Gy

Cisplatin

Intervention Type DRUG

cisplatin IV injection over 3 hours

5-FU

Intervention Type DRUG

5-FU IV 24 hours continuous infusion

Interventions

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Radiotherapy

External beam radiotherapy with curative intent, at least 66 Gy

Intervention Type RADIATION

Cisplatin

cisplatin IV injection over 3 hours

Intervention Type DRUG

5-FU

5-FU IV 24 hours continuous infusion

Intervention Type DRUG

Other Intervention Names

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CDDP 5-fluorouracil

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No