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Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Nedaplatin

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nedaplatin

Cisplatin

Arm Description

Nedplatin combine with IMRT

Cisplatin combine with IMRT

Outcomes

Primary Outcome Measures

Progress-free survival

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Secondary Outcome Measures

Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients.

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)

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)

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)

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)

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

Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy.

Cost-effectiveness analysis

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

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.

Full Information

NCT ID

NCT01540136

First Posted

February 22, 2012

Last Updated

October 27, 2016

Sponsor

Sun Yat-sen University

Collaborators

Guangzhou Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Meizhou City Hospital Of Guangdong Provience

1. Study Identification

Unique Protocol Identification Number

NCT01540136

Brief Title

Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

Official Title

A Randomized Phase III Non-inferiority Study of Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Guangzhou Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University, Meizhou City Hospital Of Guangdong Provience

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.

Detailed Description

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced NPC. Cisplatin-based chemotherapy has been shown to have higher response rates in NPC than noncisplatin regimens. However, the patients' compliance was unsatisfactory because the obvious gastrointestinal toxicity of cisplatin. Nedaplatin is the new second generation platinum and it has slight gastrointestinal reaction. Our trial is in order to study the effectiveness of nedaplatin or cisplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregionally advanced NPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nedaplatin

Arm Type

Experimental

Arm Description

Nedplatin combine with IMRT

Arm Title

Cisplatin

Arm Type

Active Comparator

Arm Description

Cisplatin combine with IMRT

Intervention Type

Drug

Intervention Name(s)

Nedaplatin

Other Intervention Name(s)

NDP

Intervention Description

Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

Primary Outcome Measure Information:

Title

Progress-free survival

Description

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients.

Description

Time Frame

4 weeks

Title

Complete Response (CR)

Description

Time Frame

after the completion of the chemoradiotherapy treatment (up to 9 weeks)

Title

Overall Survival(OS)

Description

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.

Time Frame

2 years

Title

Locoregional Relapse-Free Survival(LRRFS)

Description

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.

Time Frame

2 years

Title

Distant Metastasis-Free Survival (DMFS)

Description

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.

Time Frame

2 years

Title

Anti-neoplasms sensitization effects of chemotherapy to radiotherapy

Description

Tumor response will be evaluated by physical examination and nasopharyngoscopy when radiotherapy in 20Gy、40Gy、70Gy.

Time Frame

radiotherapy in 20Gy、40Gy、70Gy

Title

Cost-effectiveness analysis

Description

Time Frame

completion of chemoradiotherapy

Title

Correlate effects of CCRT with biomarkers of response and predictors of long-term outcome

Description

Time Frame

before chemoradiotherapy and after chemoradiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HaiQiang Mai, MD,Ph.D

Organizational Affiliation

Cancer center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

20085903

Citation

Zheng J, Wang G, Yang GY, Wang D, Luo X, Chen C, Zhang Z, Li Q, Xu W, Li Z, Wang D. Induction chemotherapy with nedaplatin with 5-FU followed by intensity-modulated radiotherapy concurrent with chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Jpn J Clin Oncol. 2010 May;40(5):425-31. doi: 10.1093/jjco/hyp183. Epub 2010 Jan 19.

Results Reference

background

PubMed Identifier

17332057

Citation

Fuwa N, Kodaira T, Tachibana H, Nakamura T, Daimon T. Dose escalation study of nedaplatin with 5-fluorouracil in combination with alternating radiotherapy in patients with head and neck cancer. Jpn J Clin Oncol. 2007 Mar;37(3):161-7. doi: 10.1093/jjco/hyl138. Epub 2007 Mar 1.

Results Reference

background

PubMed Identifier

17966212

Citation

Tanaka T, Yukawa K, Umesaki N. Radiation reduces carboplatin sensitivity and enhances nedaplatin sensitivity in cervical squamous cell carcinoma in vitro. Eur J Gynaecol Oncol. 2007;28(5):352-5.

Results Reference

background

PubMed Identifier

22056739

Citation

Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. doi: 10.1093/jnci/djr432. Epub 2011 Nov 4.

Results Reference

background

PubMed Identifier

11956263

Citation

Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. doi: 10.1200/JCO.2002.08.149.

Results Reference

background

PubMed Identifier

11230478

Citation

Ma J, Mai HQ, Hong MH, Min HQ, Mao ZD, Cui NJ, Lu TX, Mo HY. Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma. J Clin Oncol. 2001 Mar 1;19(5):1350-7. doi: 10.1200/JCO.2001.19.5.1350.

Results Reference

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PubMed Identifier

34928359

Citation

Tang QN, Liu LT, Qi B, Guo SS, Luo DH, Sun R, Sun XS, Chen DP, Guo L, Mo HY, Wang P, Liu SL, Liang YJ, Li XY, Yang ZC, Chen QY, Mai HQ, Tang LQ. Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma: A 5-Year Follow-up Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2138470. doi: 10.1001/jamanetworkopen.2021.38470.

Results Reference

derived

PubMed Identifier

29501366

Citation

Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. doi: 10.1016/S1470-2045(18)30104-9. Epub 2018 Feb 28.

Results Reference

derived

Links:

URL

http://www.nlm.nih.gov/medlineplus/

Description

cancer

URL

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Description

cisplatin

URL

http://druginfo.nlm.nih.gov/drugportal/drugportal.jsp

Description

nedaplatin

Learn more about this trial

Concurrent Chemoradiotherapy With Nedaplatin Versus Cisplatin in Nasopharyngeal Carcinoma

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