Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT01245959 |
Recruitment Status : Unknown
Verified January 2014 by Jun Ma, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : November 23, 2010
Last Update Posted : February 13, 2014
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Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Carcinoma | Drug: Docetaxel, cisplatin and fluorouracil Radiation: Concurrent chemoradiotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 476 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Randomized Trial Comparing Induction Chemotherapy Plus Concurrent Chemoradiotherapy With Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | April 2016 |
Estimated Study Completion Date : | April 2018 |
Arm | Intervention/treatment |
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Experimental: Induction chemotherapy and concurrent chemoradiotherapy
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
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Drug: Docetaxel, cisplatin and fluorouracil
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Other Name: TPF induction chemotherapy Radiation: Concurrent chemoradiotherapy Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin |
Active Comparator: Concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
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Radiation: Concurrent chemoradiotherapy
Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
Other Name: Radical radiotherapy and concurrent cisplatin |
- Failure-free survival [ Time Frame: 3-year ]Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
- Overall survival [ Time Frame: 3-year ]Overall survival is calculated from randomization to death from any cause.
- Locoregional failure-free survival [ Time Frame: 3-year ]The latency (ie, time from randomisation) to the first locoregional failure
- Distant failure-free survival [ Time Frame: 3-year ]The latency (ie, time from randomisation) to the first remote failure
- The initial response rates after treatments [ Time Frame: A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy ]
- Toxic effects [ Time Frame: During and after treatment ]
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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
- Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition).
- No evidence of distant metastasis (M0).
- Satisfactory performance status: Karnofsky scale (KPS) > 70.
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion Criteria:
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age ≥60 years or <18 years.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional 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): NCT01245959
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, Professor, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01245959 |
Other Study ID Numbers: |
YP2010171 |
First Posted: | November 23, 2010 Key Record Dates |
Last Update Posted: | February 13, 2014 |
Last Verified: | January 2014 |
Nasopharyngeal carcinoma Concurrent chemoradiotherapy Induction 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 Docetaxel Fluorouracil Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |