Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT00677118 |
Recruitment Status : Unknown
Verified March 2010 by Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : May 13, 2008
Last Update Posted : July 12, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Carcinoma | Drug: Cisplatin,fluorouracil Drug: Cisplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 506 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Prospective Randomized Trial Comparing Concurrent Chemoradiotherapy Plus Adjuvant Chemotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma |
Study Start Date : | June 2006 |
Estimated Primary Completion Date : | March 2015 |
Estimated Study Completion Date : | March 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Concurrent and adjuvant
Concurrent chemoradiotherapy plus adjuvant chemotherapy
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Drug: Cisplatin,fluorouracil
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.
Other Name: Cisplatin and fluorouracil |
Active Comparator: Concurrent
Concurrent chemoradiotherapy
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Drug: Cisplatin
Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. |
- Failure-free survival [ Time Frame: 2-yr ]Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.
- Overall survival, distant failure-free survival and locoregional failure-free survival [ Time Frame: 2-yr ]Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.
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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
- Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
- No evidence of distant metastasis (M0)
- Performance status: KPS ≥70
- With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
- Renal: creatinine clearance ≥60ml/min
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
- Written informed consent
Exclusion Criteria:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age ≥70 or <18
- With a history of renal disease
- Prior malignancy
- Previous chemotherapy or radiotherapy
- Patient is pregnant or lactating
- Unstable cardiac disease requiring treatment.
- Emotion disturbance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677118
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Study Chair: | Jun Ma, M.D. | Sun Yat-sen University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jun Ma, Sun Yat-sen University Cancer Center |
ClinicalTrials.gov Identifier: | NCT00677118 |
Other Study ID Numbers: |
YP2008004 |
First Posted: | May 13, 2008 Key Record Dates |
Last Update Posted: | July 12, 2013 |
Last Verified: | March 2010 |
Nasopharyngeal carcinoma Concurrent chemoradiotherapy Adjuvant chemotherapy Clinical trial |
Carcinoma Nasopharyngeal 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 Cisplatin Fluorouracil Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |