Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy

Nasopharyngeal Carcinoma Clinical Trial

— NPC-GTV  

Official title:

Reducing Target Volumes in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy: A Phase 3, Multicentre, Non-inferiority, Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04384627
• Other study ID #: 5010-2019-09
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 1, 2019
• Est. completion date: October 1, 2026

Study information

• Verified date: May 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the long-term locoregional control, survival rate, late toxicity and quality of life after reducing the target volume in patients with locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy.

Description:

This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly-diagnosed locoregionally advanced nasopharyngeal carcinoma patients treated with induction chemotherapy plus concurrent chemoradiotherapy. The intervention is delineating the gross tumor volume according to pretreatment tumor extension (the pre-IC GTV group) or post-induction chemotherapy tumor extension (the post-IC GTV group). The objective is to compare the long-term locoregional control, survival rate, late toxicity and quality of life between the two groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 445
• Est. completion date: October 1, 2026
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• histologic confirmation of nonkeratinizing nasopharyngeal carcinoma; no previous treatment for cancer; nondistant metastatic, newly diagnosed stage III to IVa disease that was staged according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); planned to receive 3 cycles of Induction Chemotherapy (regimens included docetaxel and cisplatin; docetaxel, cisplatin, and fluorouracil; and gemcitabine and cisplatin); and adequate hematologic, renal, and hepatic function.

Exclusion Criteria:

• younger than 18 years or elder than 70 years; receipt of treatment with palliative intent; a history of cancer; receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx or neck; lactation or pregnancy; or severe coexisting illness; had disease progress after IC

Related Conditions & MeSH terms

• Carcinoma
• Induction Chemotherapy
• Nasopharyngeal Carcinoma
• Radiotherapy

Intervention

Radiation:
• Delineating the GTV according to the pretreatment or post-IC tumor extension
Delineating the GTV according to the pretreatment or post-IC tumor extension

Locations

Country	Name	City	State
China	First People's Hospital of Foshan, Foshan	Foshan
China	People's Hospital of Zhongshan City	Zhongshan

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Research Institute of Zhongshan City, First People's Hospital of Foshan

Country where clinical trial is conducted

China, 

References & Publications (6)

McDowell LJ, Rock K, Xu W, Chan B, Waldron J, Lu L, Ezzat S, Pothier D, Bernstein LJ, So N, Huang SH, Giuliani M, Hope A, O'Sullivan B, Bratman SV, Cho J, Kim J, Jang R, Bayley A, Ringash J. Long-Term Late Toxicity, Quality of Life, and Emotional Distress — View Citation

Sommat K, Ong WS, Hussain A, Soong YL, Tan T, Wee J, Fong KW. Thyroid V40 Predicts Primary Hypothyroidism After Intensity Modulated Radiation Therapy for Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):574-580. doi: 10.1016/j.ijro — View Citation

Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tan — View Citation

Yang H, Chen X, Lin S, Rong J, Yang M, Wen Q, Shang C, He L, Ren P, Xu S, Zhang J, Liu Q, Pang H, Shi X, Fan J, Sun X, Ma D, Tan B, Zhang T, Zhang L, Hu D, Du X, Zhang Y, Wen S, Zhang X, Wu J. Treatment outcomes after reduction of the target volume of int — View Citation

Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L — View Citation

Zhao C, Miao JJ, Hua YJ, Wang L, Han F, Lu LX, Xiao WW, Wu HJ, Zhu MY, Huang SM, Lin CG, Deng XW, Xie CH. Locoregional Control and Mild Late Toxicity After Reducing Target Volumes and Radiation Doses in Patients With Locoregionally Advanced Nasopharyngeal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival (RFS)	the time from randomization to documented locoregional recurrence or death from any cause	3 year
Secondary	Overall survival (OS)	the time from randomization to documented death from any cause	3 year
Secondary	Late toxicities	Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria	3 months
Secondary	Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)	Patient-reported QoL	3 year
Secondary	Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)	Patient-reported QoL	3 year
Secondary	Distant metastasis-free survival (DMFS)	DMFS was calculated from randomization to documented distant metastasis or death.	3 year
Secondary	Acute toxicities	Occur within 3 months after IMRT	3 months