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Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Chemoradiation, Nasopharyngeal Carcinoma

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Trial Information

Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

3-year progress free survival(PFS)

Outcome Description:

PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups.

Outcome Time Frame:

3 years after the inception assignment

Safety Issue:

No

Principal Investigator

Xiaozhong Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital

Authority:

China: Food and Drug Administration

Study ID:

ZhejiangCH13

NCT ID:

NCT01536223

Start Date:

April 2012

Completion Date:

February 2015

Related Keywords:

  • Chemoradiation
  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Carcinoma (NPC)
  • cisplatin and 5-fluorouracil (PF)
  • docetaxel,cisplatin and 5-fluorouracil(TPF)
  • Neoadjuvant Chemotherapy
  • intensity modulated radiotherapy(IMRT)
  • Carcinoma
  • Nasopharyngeal Neoplasms

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