Clinical trial NCT04136886: Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma
Official title: Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: concurrent chemotherapy
IMRT
recurrent NPC
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: JiangXi Province Tumor Hospital
name: Fujian Province Tumor Hospital
name: SiChuan Province Tumor Hospital
name: Hunan Province Tumor Hospital
name: YuNan Province Tumor Hospital
name: GuiZhou Province Tumor Hospital
name: Hainan Cancer Hospital
name: Tongji Hospital
name: Second Affiliated Hospital of Nanchang University
name: Wuhan University
name: First Hospital of FoShan City
First posted: 2019-10-23
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

Eligibility criteria: Inclusion Criteria:

* 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;

  2.No evidence of distant metastasis

  3.More than 1 year from the end of the first course of radiotherapy

  4.Male, or female not in the phase of lactating or pregnancy

  5.ECOG 0-2

  6.Aged 18-70 years old

  7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L

  8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits

  9.Written informed consort signed

Exclusion Criteria:

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

Primary outcomes:
measure: Overall survival
timeFrame: From the beginning the IMRT to 3 year after the end of IMRT
Secondary outcomes:
measure: Number of participants with severe acute toxicities as assessed by CTCAE v3.0
timeFrame: From the beginning of IMRT to 3 months after the end of IMRT
measure: Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
timeFrame: From 3 months after the end of IMRT to 1 year after the end of IMRT
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: WangHanYu
state: Guangdong
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.