A Multicenter Trial Comparing Multi-course Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nasopharyngeal Carcinoma |
Drug: neoadjuvant chemotherapy plus concurrent chemoradiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Trial Comparing Neoadjuvant Chemotherapy Followed by CCRT v.s. CCRT Alone in Locoregionally Advanced Nasopharyngeal Carcinoma |
- distant metastasis free survival,disease free survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]
- overall survival [ Time Frame: 5-Yr ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 400 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: B
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
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.
Other Name: Neoadjuvant Chemotherapy Followed by CCRT
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Sumei Cao, Ph. D. | 86-20-8734-3050 | caosumei@mail/sysu.edu.cn |
| China, Guangdong | |
| Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Sumei Cao, Ph. D 86-20-8734-3050 caosumei@mail.sysu.edu.cn | |
| Principal Investigator: Minghuang Hong, MD | |
| Study Chair: | Minghuang Hong, MD | Sun Yet sen Cancer Center, China |
More Information
No publications provided
| Responsible Party: | Hong Ming-huang, Sun Yat-sen University Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00705627 History of Changes |
| Other Study ID Numbers: | 2007047 |
| Study First Received: | June 24, 2008 |
| Last Updated: | July 28, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sun Yat-sen University:
|
nasopharyngeal carcinoma neoadjuvant chemotherapy concurrent chemotherapy randomized controlled clinical trials |
Additional relevant MeSH terms:
|
Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms |
Neoplasms by Site Nasopharyngeal Diseases Carcinoma Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013