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

Primary Purpose

Nasopharyngeal Carcinoma, Induction Chemotherapy, Radiotherapy

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pre-IC GTV

Post-IC GTV

Arm Description

The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension

The gross tumor volume (GTV) is delineated according to the post-IC tumor extension

Outcomes

Primary Outcome Measures

Relapse-free survival (RFS)

the time from randomization to documented locoregional recurrence or death from any cause

Secondary Outcome Measures

Overall survival (OS)

the time from randomization to documented death from any cause

Late toxicities

Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria

Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)

Patient-reported QoL

Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)

Patient-reported QoL

Distant metastasis-free survival (DMFS)

DMFS was calculated from randomization to documented distant metastasis or death.

Acute toxicities

Occur within 3 months after IMRT

Full Information

NCT ID

NCT04384627

First Posted

May 8, 2020

Last Updated

May 18, 2023

Sponsor

Sun Yat-sen University

Collaborators

First People's Hospital of Foshan, Cancer Research Institute of Zhongshan City

1. Study Identification

Unique Protocol Identification Number

NCT04384627

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

October 30, 2024 (Anticipated)

Study Completion Date

October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

First People's Hospital of Foshan, Cancer Research Institute of Zhongshan City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma, Induction Chemotherapy, Radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Multicentre, Non-inferiority, Randomised controlled trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

445 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pre-IC GTV

Arm Type

Active Comparator

Arm Description

The gross tumor volume (GTV) is delineated according to the pretreatment tumor extension

Arm Title

Post-IC GTV

Arm Type

Experimental

Arm Description

The gross tumor volume (GTV) is delineated according to the post-IC tumor extension

Intervention Type

Radiation

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Relapse-free survival (RFS)

Description

the time from randomization to documented locoregional recurrence or death from any cause

Time Frame

3 year

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

the time from randomization to documented death from any cause

Time Frame

3 year

Title

Late toxicities

Description

Occur 3 months after IMRT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria

Time Frame

3 months

Title

Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)

Description

Patient-reported QoL

Time Frame

3 year

Title

Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)

Description

Patient-reported QoL

Time Frame

3 year

Title

Distant metastasis-free survival (DMFS)

Description

DMFS was calculated from randomization to documented distant metastasis or death.

Time Frame

3 year

Title

Acute toxicities

Description

Occur within 3 months after IMRT

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ling-Long Tang

Organizational Affiliation

Sun Yat-sen University Cancer Centr

Official's Role

Principal Investigator

Facility Information:

Facility Name

First People's Hospital of Foshan, Foshan

City

Foshan

Country

China

Facility Name

People's Hospital of Zhongshan City

City

Zhongshan

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31150573

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, 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.

Results Reference

result

PubMed Identifier

27686945

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, 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.

Results Reference

result

PubMed Identifier

30954521

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 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.

Results Reference

result

PubMed Identifier

28864073

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 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.

Results Reference

result

PubMed Identifier

30191868

Citation

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.

Results Reference

result

PubMed Identifier

28581397

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.ijrobp.2017.03.007. Epub 2017 Mar 14.

Results Reference

result

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

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