The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

NCT01187238 | Completed Phase 2 DMC

• 1 other identifier: CH-HN-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma; Stage II; Intensity-modulated radiotherapy; Concurrent chemoradiotherapy; Cisplatin

Outcome Measures

Primary Outcomes (1)

• Acute toxicities

  Acute toxicity will be measured by CTCAE3.0

  2 years

Secondary Outcomes (1)

• Long term treatment results

  5 years

Study Arms (2)

Arm1-radical radiotherapy alone group

NO INTERVENTION

Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone

Arm2-concurrent chemoradiotherapy group

EXPERIMENTAL

Arm2-concurrent chemoradiotherapy group, the eligibility patients will received radiotherapy the same as radical radiotherapy arm,and also will received the concurrent chemotherapy wiht the regimen consist of cisplatin 40mg/m2, weekly for 7weeks.

Drug: cisplatin

Interventions

cisplatin DRUG

in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7

Also known as: DDP

Arm2-concurrent chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pathological confirmed squamous cell carcinoma, WHO II-III type,
• clinical stage II (UICC 7th edition, 2009)
• Karnovsky performance score \> 70
• first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer.
• anticipated life span more than 6 month
• Hemoglobin \> 120g/L, WBC \> 4.0x10\*9/L, Plt \> 100x10\*9/L
• liver and renal function under the 1.25 normal upper limit
• with written consent information

You may not qualify if:

• have other cancer history
• have chemotherapy history
• have radiotherapy history
• evidence showed distant metastasis or other cancer
• other severe medical comorbidity

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (3)

Cancer hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Zhejiang province cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

Cancer hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (5)

• Kam MK, Leung SF, Zee B, Chau RM, Suen JJ, Mo F, Lai M, Ho R, Cheung KY, Yu BK, Chiu SK, Choi PH, Teo PM, Kwan WH, Chan AT. Prospective randomized study of intensity-modulated radiotherapy on salivary gland function in early-stage nasopharyngeal carcinoma patients. J Clin Oncol. 2007 Nov 1;25(31):4873-9. doi: 10.1200/JCO.2007.11.5501.

  PMID: 17971582 BACKGROUND

• Chua DT, Sham JS, Kwong DL, Au GK. Treatment outcome after radiotherapy alone for patients with Stage I-II nasopharyngeal carcinoma. Cancer. 2003 Jul 1;98(1):74-80. doi: 10.1002/cncr.11485.

  PMID: 12833458 BACKGROUND

• Chua DT, Ma J, Sham JS, Mai HQ, Choy DT, Hong MH, Lu TX, Au GK, Min HQ. Improvement of survival after addition of induction chemotherapy to radiotherapy in patients with early-stage nasopharyngeal carcinoma: Subgroup analysis of two Phase III trials. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1300-6. doi: 10.1016/j.ijrobp.2006.02.016. Epub 2006 Jun 5.

  PMID: 16750333 RESULT

• Cheng SH, Tsai SY, Yen KL, Jian JJ, Chu NM, Chan KY, Tan TD, Cheng JC, Hsieh CY, Huang AT. Concomitant radiotherapy and chemotherapy for early-stage nasopharyngeal carcinoma. J Clin Oncol. 2000 May;18(10):2040-5. doi: 10.1200/JCO.2000.18.10.2040.

  PMID: 10811668 RESULT

• Huang X, Chen X, Zhao C, Wang J, Wang K, Wang L, Miao J, Cao C, Jin T, Zhang Y, Qu Y, Chen X, Liu Q, Zhang S, Zhang J, Luo J, Xiao J, Xu G, Gao L, Yi J. Adding Concurrent Chemotherapy to Intensity-Modulated Radiotherapy Does Not Improve Treatment Outcomes for Stage II Nasopharyngeal Carcinoma: A Phase 2 Multicenter Clinical Trial. Front Oncol. 2020 Aug 7;10:1314. doi: 10.3389/fonc.2020.01314. eCollection 2020.

  PMID: 32850414 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Li Gao, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 24, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2017
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

CN (3)