Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

NCT04136886 | Recruiting Phase 3

• 1 other identifier: B2019-070-01
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Conditions

Nasopharyngeal Carcinoma

Keywords

concurrent chemotherapy; IMRT; recurrent NPC

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the beginning the IMRT to 3 year after the end of IMRT

Secondary Outcomes (2)

• Number of participants with severe acute toxicities as assessed by CTCAE v3.0

  From the beginning of IMRT to 3 months after the end of IMRT

• Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

  From 3 months after the end of IMRT to 1 year after the end of IMRT

Study Arms (2)

IMRT and concurrent cisplatin

ACTIVE COMPARATOR

IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction

Drug: Cisplatin; Radiation: IMRT

IMRT alone

EXPERIMENTAL

IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction

Radiation: IMRT

Interventions

Cisplatin DRUG

cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction

IMRT and concurrent cisplatin

IMRT RADIATION

Radiation: IMRT IMRT is to give 60Gy in 27 fraction

IMRT alone; IMRT and concurrent cisplatin

Eligibility Criteria

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

You may qualify if:

• Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
• No evidence of distant metastasis
• More than 1 year from the end of the first course of radiotherapy
• Male, or female not in the phase of lactating or pregnancy
• ECOG 0-2
• Aged 18-70 years old
• WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
• Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
• Written informed consort signed

You may not qualify if:

• Only regionally recurrence
• Evidence of distant metastasis
• Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
• Severe, active co-morbidity
• Prior anti-tumor treatment after diagnosis of local recurrence
• MRI was not performed 3 months after the first course of radiotherapy
• Abnormal function of heart, brain and lungs, etc
• Lactation or pregnancy
• Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

Sponsors & Collaborators

• Sun Yat-sen University: lead
• JiangXi Province Tumor Hospital: collaborator
• Fujian Province Tumor Hospital: collaborator
• SiChuan Province Tumor Hospital: collaborator
• Hunan Province Tumor Hospital: collaborator
• YuNan Province Tumor Hospital: collaborator
• GuiZhou Province Tumor Hospital: collaborator
• Hainan Cancer Hospital: collaborator
• Tongji Hospital: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Wuhan University: collaborator
• First Hospital of FoShan City: collaborator

Study Sites (1)

WangHanYu

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (4)

• Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29.

  PMID: 22209574 BACKGROUND

• Xiao WW, Huang SM, Han F, Wu SX, Lu LX, Lin CG, Deng XW, Lu TX, Cui NJ, Zhao C. Local control, survival, and late toxicities of locally advanced nasopharyngeal carcinoma treated by simultaneous modulated accelerated radiotherapy combined with cisplatin concurrent chemotherapy: long-term results of a phase 2 study. Cancer. 2011 May 1;117(9):1874-83. doi: 10.1002/cncr.25754. Epub 2010 Nov 16.

  PMID: 21509764 BACKGROUND

• Seo Y, Yoo H, Yoo S, Cho C, Yang K, Kim MS, Choi C, Shin Y, Lee D, Lee G. Robotic system-based fractionated stereotactic radiotherapy in locally recurrent nasopharyngeal carcinoma. Radiother Oncol. 2009 Dec;93(3):570-4. doi: 10.1016/j.radonc.2009.10.018. Epub 2009 Nov 16.

  PMID: 19919887 BACKGROUND

• Guan Y, Liu S, Wang HY, Guo Y, Xiao WW, Chen CY, Zhao C, Lu TX, Han F. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma. Chin J Cancer. 2016 Feb 15;35:20. doi: 10.1186/s40880-016-0081-7.

  PMID: 26879049 RESULT

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

Central Study Contacts

Fei Han, doctor

CONTACT

8620-87343030; hanfei@sysucc.org.cn

hanyu wang, doctor

CONTACT

8620-87343418; wanghany@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 23, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

CN (1)