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Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma (CTVp1-NPC)

Primary Purpose

Nasopharyngeal Carcinoma, Intensity-Modulated Radiotherapy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Reduction CTVp1
Non-reduction CTVp1
Sponsored by
Zhongshan People's Hospital, Guangdong, China
About
Eligibility
Locations
Arms
Outcomes
Full info

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(WHO II-III); newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically. planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0:No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies,node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy ) no previous treatment for cancer; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); between 18 and 70 years old; adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: receipt of treatment with palliative intent; receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx; had disease progress after neoadjuvant chemotherapy in local advantage NPC presence of distant metastasis; Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; lactation or pregnancy; Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.

Sites / Locations

  • Zhongshan City People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Reduction CTVp1

Non-reduction CTVp1

Arm Description

CTVp1=GTVp+5mm

CTVp1=GTVp+5mm+whole nasopharynx

Outcomes

Primary Outcome Measures

Local Relapse-free Survival(LRFS)
the time from randomization to documented local recurrence or death from any cause
Incidence of hearing impairment worse than graded 2
audiometry and symptoms graded according to the CTCAE (version 5.0).

Secondary Outcome Measures

Overall survival (OS)
the time from randomization to documented death from any cause
Regional Relapse-free Survival(RRFS)
the time from randomization to documented regional recurrence or death from any cause
Distant metastasis-free survival (DMFS)
calculated from randomization to documented distant metastasis or death
Acute toxicities
Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
Late toxicities
3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
Patient reported quality-of-life data and higher scores indicated more severe symptoms
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
Patient reported quality-of-life data and higher scores indicated more severe symptoms
radiation-induced otitis media with effusion (OME)
Evaluated by tympanometry
V60Gy
Volume that received at least 60Gy

Full Information

First Posted
July 25, 2023
Last Updated
August 8, 2023
Sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborators
Sun Yat-sen University Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT05994170
Brief Title
Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma
Acronym
CTVp1-NPC
Official Title
Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma Treated With Intensity-modulated Radiotherapy(IMRT): A Phase 3, Multicentre, Randomised Controlled Trial(CTVp1-NPC)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Actual)
Primary Completion Date
August 4, 2026 (Anticipated)
Study Completion Date
September 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan People's Hospital, Guangdong, China
Collaborators
Sun Yat-sen University Cancer Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the long-term local control, survival rate, acute and late radiation related toxicities, quality of life after reducing high risk primary tumor clinical target volumes (CTVp1) in non-metastatic nasopharyngeal carcinoma treated with IMRT.
Detailed Description
This phase 3, multicenter,randomized controlled clinical trial recruits patients with newly-diagnosed non-metastatic nasopharyngeal carcinoma patients treated with IMRT. The intervention is delineating high risk primary tumor clinical target volumes (CTVp1) as GTV+5mm or GTV+5mm+whole nasopharynx. The objective is to compare the long-term local control, survival rate, acute and late radiation related toxicities 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, Intensity-Modulated Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
454 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reduction CTVp1
Arm Type
Experimental
Arm Description
CTVp1=GTVp+5mm
Arm Title
Non-reduction CTVp1
Arm Type
Placebo Comparator
Arm Description
CTVp1=GTVp+5mm+whole nasopharynx
Intervention Type
Radiation
Intervention Name(s)
Reduction CTVp1
Intervention Description
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as 5mm margin from GTVp,including pre-induction chemotherapy tumor extension( CTVp1=GTVp+5mm)
Intervention Type
Radiation
Intervention Name(s)
Non-reduction CTVp1
Intervention Description
High Risk Primary Tumor Clinical Target Volumes (CTVp1) is defined as whole nasopharynx as well as 5mm margin from GTVp( CTVp1=GTVp+5mm+whole nasopharynx)
Primary Outcome Measure Information:
Title
Local Relapse-free Survival(LRFS)
Description
the time from randomization to documented local recurrence or death from any cause
Time Frame
3 years
Title
Incidence of hearing impairment worse than graded 2
Description
audiometry and symptoms graded according to the CTCAE (version 5.0).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
the time from randomization to documented death from any cause
Time Frame
3 years
Title
Regional Relapse-free Survival(RRFS)
Description
the time from randomization to documented regional recurrence or death from any cause
Time Frame
3 years
Title
Distant metastasis-free survival (DMFS)
Description
calculated from randomization to documented distant metastasis or death
Time Frame
3 years
Title
Acute toxicities
Description
Occur within 3 months after IMRT according Common Terminology Criteria for Adverse Events Version 5.0
Time Frame
3 months
Title
Late toxicities
Description
3 months after completion of radiotherapy graded according to both the Radiation Therapy Oncology Group criteria and the CTCAE (version 5.0)
Time Frame
3 years
Title
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-H&N35)
Description
Patient reported quality-of-life data and higher scores indicated more severe symptoms
Time Frame
3 years
Title
Functional Assessment of Cancer Therapy-Head and Neck questionnaire (EORTC QLQ-C30)
Description
Patient reported quality-of-life data and higher scores indicated more severe symptoms
Time Frame
3 years
Title
radiation-induced otitis media with effusion (OME)
Description
Evaluated by tympanometry
Time Frame
3 years
Title
V60Gy
Description
Volume that received at least 60Gy
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologic confirmation of nonkeratinizing nasopharyngeal carcinoma(WHO II-III); newly diagnosed stage I to IVa according to the American Joint Committee on Cancer-Union for International Cancer Control 8th edition stage-classification system nasopharyngeal mass confined to one side of nasopharynx and did not exceed the midline(the line between the nasal septum and the midpoint of spinal cord/medulla) detected by electronic nasopharyngoscope (ENS) and magnetic resonance imaging (MRI). Pathological biopsy was recommended if it was unclear whether tumor invaded the contralateral side radiographically. planned to receive curative IMRT, Chemotherapy drugs should be administered according to Chinese Society of Clinical Oncology (CSCO) guidelines depending on the TNM stage;(T1N0: No chemotherapy required;T2N0:No chemotherapy or concurrent cisplatin chemoradiotherapy if there are adverse prognostic indicators such as Epstein-Barr virus (EBV) DNA>4000 copies,node >3cm or with extranodal extension;T1-2N1: concurrent cisplatin chemoradiotherapy;T3N0: concurrent cisplatin chemoradiotherapy; stage III-Iva: platinum-based neoadjuvant chemotherapy+ concurrent cisplatin chemoradiotherapy+/-metronomic capecitabine therapy ) no previous treatment for cancer; a Karnofsky performance-status score of at least 70 (on a scale from 0 to 100, with lower scores indicating greater disability); between 18 and 70 years old; adequate hematologic, renal, and hepatic function: Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;Adequate liver function: ALT and AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;Adequate renal function: BUN and CRE ≤ 1.5×ULN , endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: receipt of treatment with palliative intent; receipt of previous treatment (radiotherapy, chemotherapy, or surgery [except diagnostic procedures]) to the nasopharynx; had disease progress after neoadjuvant chemotherapy in local advantage NPC presence of distant metastasis; Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma; Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment; lactation or pregnancy; Any other condition including Mental disorder,drug or alcohol addition;do not have full capacity for civil acts.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gui-qiong Xu
Phone
+8613528109888
Email
donna_shee@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gui-qiong Xu
Organizational Affiliation
Zhongshan People's Hospital, Guangdong, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan City People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528403
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiqiong Xu
Phone
+8613528109888
Email
donna_shee@163.com
First Name & Middle Initial & Last Name & Degree
Yu-long Xie, MD
Phone
+8615625031643
Email
xieyl1@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Reducing High Risk Primary Tumor Clinical Target Volumes (CTVp1) in Non-metastatic Nasopharyngeal Carcinoma

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