Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT03047265 | Active Not Recruiting Phase 2

• 1 other identifier: 308-2016-02-01
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year progress free survival(PFS)

  PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups

  3 years

Secondary Outcomes (1)

• overall survival(OS)

  2 years ,3 years and 5 years

Study Arms (2)

Paclitaxel

EXPERIMENTAL

Paclitaxel plus Cisplatin combine with IMRT

Drug: Paclitaxel

Cisplatin

ACTIVE COMPARATOR

Cisplatin combine with IMRT

Drug: Cisplatin

Interventions

Paclitaxel DRUG

Paclitaxel 135mg / m2 D1, DDP 20mg / m2 D1-4, D1,D29 of RT, a total of 2 courses.

Also known as: TAXOL

Paclitaxel

Cisplatin DRUG

Cisplatin 100mg / m2 , D1,D22,D43 of RT, a total of 3 courses.

Also known as: DDP

Cisplatin

Eligibility Criteria

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

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing carcinoma.
• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
• Original clinical staged as IVa-IVb（according to the 7th AJCC edition）.
• Male and no pregnant female
• Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.
• WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
• With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
• With normal renal function test (Creatinine ≤ 1.5×ULN)
• Written informed consent.

You may not qualify if:

• Patients have evidence of relapse or distant metastasis Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
• Receiving radiotherapy or chemotherapy previously
• The presence of uncontrolled life-threatening illness
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
• Concurrent systemic steroid therapy
• HIV positive
• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• Langendijk JA, Leemans CR, Buter J, Berkhof J, Slotman BJ. The additional value of chemotherapy to radiotherapy in locally advanced nasopharyngeal carcinoma: a meta-analysis of the published literature. J Clin Oncol. 2004 Nov 15;22(22):4604-12. doi: 10.1200/JCO.2004.10.074.

  PMID: 15542811 BACKGROUND

• 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.

  PMID: 22056739 BACKGROUND

• Lin JC, Liang WM, Jan JS, Jiang RS, Lin AC. Another way to estimate outcome of advanced nasopharyngeal carcinoma--is concurrent chemoradiotherapy adequate? Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):156-64. doi: 10.1016/j.ijrobp.2004.03.002.

  PMID: 15337551 BACKGROUND

• Chen WH, Tang LQ, Guo SS, Chen QY, Zhang L, Liu LT, Qian CN, Guo X, Xie D, Zeng MS, Mai HQ. Prognostic Value of Plasma Epstein-Barr Virus DNA for Local and Regionally Advanced Nasopharyngeal Carcinoma Treated With Cisplatin-Based Concurrent Chemoradiotherapy in Intensity-Modulated Radiotherapy Era. Medicine (Baltimore). 2016 Feb;95(5):e2642. doi: 10.1097/MD.0000000000002642.

  PMID: 26844482 BACKGROUND

• Garden AS, Harris J, Vokes EE, Forastiere AA, Ridge JA, Jones C, Horwitz EM, Glisson BS, Nabell L, Cooper JS, Demas W, Gore E. Preliminary results of Radiation Therapy Oncology Group 97-03: a randomized phase ii trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck. J Clin Oncol. 2004 Jul 15;22(14):2856-64. doi: 10.1200/JCO.2004.12.012.

  PMID: 15254053 BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Paclitaxel; 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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 8, 2017
• Study Start: February 4, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

CN (1)