Benefit of Adding Chemotherapy And/Or Modification of Radiotherapy Schedule for Advance Nasopharyngeal Carcinoma (T3-4N0-1M0)

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

TERMINATED

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2007-06-30

Brief Summary

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To test the therapeutic ratio of accelerated radiotherapy and/or chemotherapy on locally advanced nasopharyngeal carcinoma.

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Detailed Description

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Conditions

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Nasopharyngeal Neoplasms Carcinoma, Squamous Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Conventional RT

Intervention Type PROCEDURE

Accelerated RT

Intervention Type PROCEDURE

Cisplatin

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Undifferentiated or non-keratinizing carcinoma
* Tumor staged as T3-4 AND N0-1
* No evidence of distant metastasis (M0)
* Performance status: 0-2
* Marrow: WBC \>= 4 and platelet = 100
* Renal: creatinine clearance = 60
* Informed consent

Exclusion Criteria

* WHO type I squamous cell carcinoma or adenocarcinoma
* Age \>= 70
* Palliative intent or tumor extent mandating AP opposing facio-cervical fields
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years
* Previous radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume
* Previous chemotherapy
* Patient is pregnant or lactating

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No