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

Hospital Authority, Hong Kong

Status: Terminated

Conditions: Carcinoma, Squamous Cell; Nasopharyngeal Neoplasms

Treatments: Procedure: Conventional RT; Drug: 5-fluorouracil; Drug: Cisplatin; Procedure: Accelerated RT

Study type: Interventional

Funder types: Other

Identifiers

NCT00563862

L/M-78 to PYH 08/79

HARECCTR0500024

NPC99-02

Details and patient eligibility

About

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

Enrollment: 465 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)