Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma (ESNCCT)

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3

Conditions: Chemoradiation; Nasopharyngeal Carcinoma

Treatments: Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group; Drug: PF (cisplatin and 5-fluorouracil) group

Study type: Interventional

Funder types: Other

Identifiers

NCT01536223

ZhejiangCH13

Details and patient eligibility

About

Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.

Full description

For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle.

After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)
3. No evidence of distant metastasis(M0)
4. Performance status:KPS>70
5. With normal liver function test(ALT, AST<1.5ULN)
6. Renal:creatinine clearance >60ml/min
7. Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L.
8. With controled blood glucose for diabetes patients
9. Written informed consent

Exclusion criteria

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age>70 or <18
3. With a history of renal disease
4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0
5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume)
6. Patient is pregnant or lactating .
7. Peripheral neuropathy
8. Emotional disturbance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

PF group

Active Comparator group

Description:

the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy

Treatment:

Drug: PF (cisplatin and 5-fluorouracil) group

TPF group

Experimental group

Description:

TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy

Treatment:

Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group