A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT00705627 | Unknown Phase 3 DMC

• 1 other identifier: 2007047
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Locoregionally advanced nasopharyngeal carcinoma (NPC)(stage III, IV in UICC 2002 Classification) can be divided into two groups according to the risk of metastasis: high-risk metastasis group (T4 or N2-3) and low-risk metastasis group (T3N0-1). In low-risk metastasis group, concurrent chemoradiotherapy (CCRT) might decrease local recurrence and distance metastasis, which benefits overall survival. On the other hand, neoadjuvant chemotherapy is also associated with lower distance metastasis of advanced stage NPC. Nevertheless, CCRT alone or neoadjuvant chemotherapy alone leads to unsatisfactory results regarding to distance metastasis in patients with high-risk metastasis group. In this case, it is utmost important to investigate the new treatment combining neoadjuvant chemotherapy plus CCRT in order to improve overall survival of locoregionally advanced NPC with high-risk metastasis. In our study, in order to investigate the effect and adverse reaction of neoadjuvant chemotherapy plus CCRT on distance metastasis and locoregionally relapse, four hundred patients with high risk of distance metastasis will be randomly divided into two groups, comparing neoadjuvant chemotherapy (DDP+5FU) plus CCRT (DDP) and CCRT (DDP) alone. We aim to find out the best therapeutic regimen with lowest adverse reaction for NPCS with high risk of distance metastasis.

Conditions

Nasopharyngeal Carcinoma

Keywords

nasopharyngeal carcinoma; neoadjuvant chemotherapy; concurrent chemotherapy; randomized controlled clinical trials

Outcome Measures

Primary Outcomes (1)

• distant metastasis free survival,disease free survival

  5-Yr

Secondary Outcomes (1)

• overall survival

  5-Yr

Study Arms (1)

B

EXPERIMENTAL

Drug: cisplatin. Patients in the control arm received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy

Interventions

neoadjuvant chemotherapy plus concurrent chemoradiotherapy DRUG

Drug: cisplatin,fluorouracil. Patients received cisplatin 80mg/m2 on day 1,fluorouracil 4000mg/m2 civ 120 hours every three weeks for two cycles, then received radical radiotherapy, and cisplatin (80mg/m2 on day 1) every three weeks for three cycles during RT.

Also known as: Neoadjuvant Chemotherapy Followed by CCRT

B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with newly histologically confirmed nasopharyngeal carcinoma, including WHO II or III
• Original clinical stage must be T4 or N2-3 （UICC 2002）
• Male and no pregnant female
• Age between 18-60
• WBC ≥4,000/mm3 and PLT ≥ 100,000/mm3
• With normal liver function test (ALT、AST≤2.5×ULN)
• With normal renal function test (Creatinine ≤ 1.5×ULN)
• Performance status scale ECOG grade 0，1
• Without radiotherapy or chemotherapy
• Patients must give signed informed consent

You may not qualify if:

• Patients have evidence of relapse or distant metastasis
• The presence of uncontrolled life-threatening illness
• Receiving other ways of anti-cancer therapy
• Receiving radiotherapy or chemotherapy
• Investigator consider the patients can't finish the whole study

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Neoadjuvant Therapy; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Minghuang Hong, MD

  Sun Yet sen Cancer Center, China

  STUDY CHAIR

Central Study Contacts

Sumei Cao, Ph. D.

CONTACT

86-20-8734-5685; caosumei@mail/sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of GCP

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 26, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2017
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

CN (1)