Reducing Target Volumes in NPC Treated With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy (NPC-GTV)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Carcinoma; Radiotherapy; Induction Chemotherapy
• Intervention / Treatment: Radiation: Delineating the GTV according to the pretreatment or post-IC tumor extension

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 445
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ling-Long Tang; Phone Number: 15913149109; Email: tangll@sysucc.org.cn

Study Locations

• China
  • Foshan, China
    • First People's Hospital of Foshan, Foshan
  • Zhongshan, China
    • People's Hospital of Zhongshan City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-IC GTV; The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension	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
Experimental: Post-IC GTV; The gross tumor volume (GTV) is delineated according to the post-IC tumor extension	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-free survival (RFS)	the time from randomization to documented locoregional recurrence or death from any cause	3 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: First People's Hospital of Foshan; Cancer Research Institute of Zhongshan City
• Investigators: Principal Investigator: Ling-Long Tang, Sun Yat-sen University Cancer Centr

Publications and helpful links

General Publications

• 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, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31.
• 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, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.
• 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 Carcinoma Treated With Induction Chemotherapy (IC) Followed by Concurrent Chemoradiotherapy: 10-Year Results of a Phase 2 Study. Int J Radiat Oncol Biol Phys. 2019 Jul 15;104(4):836-844. doi: 10.1016/j.ijrobp.2019.03.043. Epub 2019 Apr 5.
• 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 intensity-modulated radiotherapy following induction chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: A prospective, multi-center, randomized clinical trial. Radiother Oncol. 2018 Jan;126(1):37-42. doi: 10.1016/j.radonc.2017.07.020. Epub 2017 Aug 29.
• 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 in Patients With Nasopharyngeal Carcinoma Treated With Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):340-352. doi: 10.1016/j.ijrobp.2018.05.060. Epub 2018 Jun 4.
• 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.ijrobp.2017.03.007. Epub 2017 Mar 14.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): October 1, 2026

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: 5010-2019-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes