Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma
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ClinicalTrials.gov Identifier: NCT01540136 |
Recruitment Status :
Completed
First Posted : February 28, 2012
Last Update Posted : October 28, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nasopharyngeal Carcinoma | Drug: Nedaplatin Drug: Cisplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 402 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Nedaplatin
Nedplatin combine with IMRT
|
Drug: Nedaplatin
Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other Name: NDP |
Active Comparator: Cisplatin
Cisplatin combine with IMRT
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Drug: Cisplatin
Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
Other Name: DDP |
- Progress-free survival [ Time Frame: 2 years ]Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.
- Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients. [ Time Frame: 4 weeks ]Administration and Monitoring Patients will be evaluated in the clinic and eligibility and informed consent obtained. Patients will be monitored for clinical toxicity by standard NIH criteria. QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30) and EORTC QLQ Head and Neck. A time period of 4 weeks will constitute the time for clinical safety monitoring.
- Complete Response (CR) [ Time Frame: after the completion of the chemoradiotherapy treatment (up to 9 weeks) ]CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
- Overall Survival(OS) [ Time Frame: 2 years ]The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
- Locoregional Relapse-Free Survival(LRRFS) [ Time Frame: 2 years ]The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: 2 years ]The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
- Anti-neoplasms sensitization effects of chemotherapy to radiotherapy [ Time Frame: radiotherapy in 20Gy、40Gy、70Gy ]Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy.
- Cost-effectiveness analysis [ Time Frame: completion of chemoradiotherapy ]The determination of cost, including direct cost drug fees, inspection fees, expenses and nursing cost; cost-effectiveness analysis, such as cost-effectiveness ratio (ratio of the direct cost and short - and long-term curative effect) and incremental cost-effectiveness ratio (i.e., increasing costs and increase short or long-term efficacy ratio).
- Correlate effects of CCRT with biomarkers of response and predictors of long-term outcome [ Time Frame: before chemoradiotherapy and after chemoradiotherapy ]Early identification of patients who will have more aggressive disease soon after diagnosis has been a major goal, we will investigate the correlate effects of CCRT with biomarkers of response and predictors of long-term outcome in these patients.
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Original clinical staged as T1-4N1-3 or T3-4N0(according to the 7th AJCC edition)
- No evidence of distant metastasis (M0)
- Male and no pregnant female
- Age between 18-65
- 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)
- Satisfactory performance status: Karnofsky scale (KPS)> 70
- 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
- Pregnancy or lactation
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): NCT01540136
China, Guangdong | |
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
Principal Investigator: | HaiQiang Mai, MD,Ph.D | Cancer center |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hai-Qiang Mai,MD,PhD, Deputy Director of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT01540136 |
Other Study ID Numbers: |
Sun Yat-sen University |
First Posted: | February 28, 2012 Key Record Dates |
Last Update Posted: | October 28, 2016 |
Last Verified: | March 2013 |
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 Nedaplatin Antineoplastic Agents |