Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

NCT ID: NCT01536223

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-02-28

Brief Summary

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.

Detailed 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.

Conditions

Chemoradiation; Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PF group

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

Group Type: ACTIVE_COMPARATOR

PF (cisplatin and 5-fluorouracil) group

Intervention Type: DRUG

the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.

TPF group

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

Group Type: EXPERIMENTAL

TPF (docetaxel plus cisplatin and 5-fluorouracil) group

Intervention Type: DRUG

3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours .

And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.

Interventions

PF (cisplatin and 5-fluorouracil) group

the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.

Intervention Type: DRUG

TPF (docetaxel plus cisplatin and 5-fluorouracil) group

3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours .

And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.

Intervention Type: DRUG

Other Intervention Names

Active Comparator group; Experiment group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaozhong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Cancer Hospital

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaozhong Chen, MD

Role: CONTACT

cxzfyun@sina.com

86-571-88122098

Weifeng Qin, MD

Role: CONTACT

qinweifeng@yahoo.com.cn

86-571-88122092

Facility Contacts

Xiaozhong Chen, MD

Role: primary

cxzfyun@sina.com

86-571-88122098

Weifeng Qin, MD

Role: backup

qinweifeng@yahoo.com.cn

86-571-88122091

References

Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20.

Reference Type: DERIVED

PMID: 30797141 (View on PubMed)

Other Identifiers

ZhejiangCH13

Identifier Type: -

Identifier Source: org_study_id