Two Cycles Versus Three Cyclle of CCRT for Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma

NCT02871518 | Unknown Phase 2 DMC

• 1 other identifier: cycle of CCRT and NPC
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase II trial to study the effectiveness of two cycles versus three cycles of Concurrent Chemoradiotherapy in treating patients with Low Risk Locoregionally Advanced Nasopharyngeal Carcinoma based on pretreatment plasma EBV DNA.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival

  Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up

  3 years

Secondary Outcomes (8)

• The shor-term toxic effects

  3 months

• Complete Response (CR)

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

• Overall Survival(OS)

  3 years

• Locoregional Relapse-Free Survival(LRRFS)

  3 years

• Distant Metastasis-Free Survival (DMFS)

  3 years

Study Arms (2)

Two cycle CCRT

EXPERIMENTAL

Concurrent cisplatin(100mg/m2,D1,D22)combine with IMRT

Drug: Cisplatin combine with IMRT

Three cycle CCRT

ACTIVE COMPARATOR

Concurrent cisplatin(100mg/m2,D1,D22 and D43)combine with IMRT

Drug: Cisplatin combine with IMRT

Interventions

Cisplatin combine with IMRT DRUG

Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT

Also known as: DDP

Two cycle CCRT

Eligibility Criteria

• Age: 18 Years - 70 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 nasopharyngeal carcinoma, including WHO II or III
• Original clinical staged as T3-4N0-3 M0 or any T、N2-3M0（according to the 7th AJCC edition）
• No evidence of distant metastasis (M0)
• Pretreatment Plasm EB Virus DNA\<4000copies/ml
• 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)

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.
• Receiving other ways of anti-cancer therapy.
• 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)

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

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

• Li YC, Li XY, Lan KQ, Cheng H, Chen J, Liu LT, Wen DX, Gu LW, Guo WP, Sun XS, Liu SL, Yang JH, Li SC, Li YF, Long HX, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Wang P, Li LB, Yang Q, Liang YJ, Jia GD, Yan JJ, Zhao C, Chen QY, Li LJ, Mai HQ, Tang LQ. Epstein-Barr virus DNA-guided chemoradiotherapy for patients with low-risk locoregionally advanced nasopharyngeal carcinoma: a secondary 5-year follow-up analysis of an open-label, randomised controlled, phase 2 non-inferiority trial. EClinicalMedicine. 2025 Oct 30;90:103615. doi: 10.1016/j.eclinm.2025.103615. eCollection 2025 Dec.

  PMID: 41245547 DERIVED

• Li XY, Luo DH, Guo L, Mo HY, Sun R, Guo SS, Liu LT, Yang ZC, Yang JH, Qiu F, Sun XS, Wang P, Liu Q, Li JB, Tang QN, Lin C, Yang Q, Liu SL, Liang YJ, Jia GD, Wen DX, Guo CY, Yan JJ, Zhao C, Chen QY, Tang LQ, Mai HQ. Deintensified Chemoradiotherapy for Pretreatment Epstein-Barr Virus DNA-Selected Low-Risk Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II Randomized Noninferiority Trial. J Clin Oncol. 2022 Apr 10;40(11):1163-1173. doi: 10.1200/JCO.21.01467. Epub 2022 Jan 6.

  PMID: 34990291 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

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)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Lin-Quan Tang, MD,PHD

CONTACT

8602087343643; tanglq@sysucc.org.cn

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: the vice director of nasopharyngeal carcinoma

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: August 18, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2021
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

CN (1)