Benefit of Adding Chemotherapy for Advance Nasopharyngeal Carcinoma (T1-4N2-3M0)

Hospital Authority, Hong Kong

Status: Unknown

Conditions: Carcinoma, Squamous Cell; Nasopharyngeal Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00563927

HARECCTR0500023

NPC99-01

L/M-77 TO PYH08/79

Details and patient eligibility

About

To test the therapeutic ratio of additional chemotheray on advanced nasopharyngeal carcinoma.

Enrollment: 340 estimated patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undifferentiated or non-keratinizing carcinoma
• Tumor staged as N2-3
• 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: Parallel Assignment

Masking: None (Open label)