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Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Neoplasms

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

IMRT using individualized CTV

IMRT using traditional CTV

Gemcitabine and cisplatin (induction chemotherapy)

Docetaxel and cisplatin (induction chemotherapy)

Cisplatin 100mg/m² concurrent chemotherapy

Cisplatin 80mg/m² concurrent chemotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring Nasopharyngeal carcinoma, Intensity modulated radiotherapy, Clinical target volume, Clinical trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
Tumor staged as T1-4N0-3M0 (according to the 7th AJCC edition), based upon the following minimum diagnostic workup within 4 weeks prior to registration:(1) history/physical examination;(2)chest X-ray, PA and lateral OR chest CT OR PET/CT;(3) pre-treatment magnetic resonance imaging (MRI) of nasopharynx and neck, pre-treatment MRI must be done at Sun Yat-sen University Cancer Center;(4) sonography OR CT of upper abdoman OR PET/CT;(5) Bone scan OR PET/CT.
Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
Adequate bone marrow function based upon the complete blood count within 2 weeks prior to registration: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
Adequate hepatic function within 2 weeks prior to registration: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
Adequate renal function within 2 weeks prior to registration: serum creatinine ≤ 133 umol/L or calculated creatinine clearance ≥ 60 ml/min.
Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
Patients must be informed of the investigational nature of this study and sign a written informed consent.

Exclusion Criteria:

Age > 65 or < 18.
Prior malignancy except adequately treated basal cell or squamous cell skin cancer outside head and neck region, in situ cervical cancer.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
Prior chemotherapy or surgery (except fine needle aspiration biopsy) to primary tumor or nodes.
Hearing loss due to sensorineural deafness（except tumor induced conductive hearing loss).
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), emotional disturbance, untreated active infectious disease, and acquired immune deficiency syndrome.
Prior allergic reaction to the study drugs involved in this protocol.

Sites / Locations

Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized CTV

Traditional CTV

Arm Description

Patients receive IMRT using individualized CTV based on disease extension risk atlas and computer-aided delineation. Gemcitabine and cisplatin induction chemotherapy or docetaxel and cisplatin induction chemotherapy and cisplatin 100mg/m² concurrent chemotherapy or cisplatin 80mg/m² concurrent chemotherapy are optional based on clinical classification.

Patients receive IMRT using traditional CTV. Gemcitabine and cisplatin induction chemotherapy or docetaxel and cisplatin induction chemotherapy and cisplatin 100mg/m² concurrent chemotherapy or cisplatin 80mg/m² concurrent chemotherapy are optional based on clinical classification.

Outcomes

Primary Outcome Measures

Local-regional recurrence-free survival rate

Local-regional recurrence-free survival is calculated from the date of randomization to the date of local or regional recurrence, whichever is first.

Secondary Outcome Measures

Overall survival rate

Overall survival is calculated from the date of randomization to the date of death from any cause.

Distant metastasis-free survival rate

Distant metastasis-free survival is calculated from the date of randomization to the date of the first distant metastasis.

Constituent ratio of local and regional recurrence pattern

Constituent ratio of local and regional recurrence pattern is defined as the proportion of in-field,marginal and out-field recurrence.

Number of participants with adverse events

Incidence of acute and late toxicity

Quality of life score measured by EORTC QLQ-C30

Quality of life is measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30).

Quality of life score measured by EORTC H&N35

Quality of life is measured by European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Questionnaire (EORTC QLQ-H&N35).

Target volumes' dose coverage and doses irradiated to organs at risk

For example, relative volume of planning target volume (PTV) receive 110%,95%,93% of the prescription doses;max dose or dose receive by 1% volume of brainstem; et,al.

Full Information

NCT ID

NCT02627807

First Posted

December 3, 2015

Last Updated

June 13, 2020

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02627807

Brief Title

Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma

Official Title

Prospective Non-inferiority Randomized Trial Comparing Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation and Traditional Clinical Target Volume in Radiotherapy for Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation with traditional CTV in intensity modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the efficacy and safety.

Detailed Description

Patients with non-keratinizing NPC T1-4N0-3M0 (AJCC/UICC staging system 7th edition) are randomly assigned to receive IMRT using individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation or IMRT using traditional CTV. IMRT is given as 2.13 Gray (Gy) per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor. Patients with T1N0M0 NPC receive IMRT only. For patients with stage T2-4N0-3M0 NPC, concurrent chemoradiotherapy (CCRT) is required and induction chemotherapy (IC) before CCRT is optional.Patients who participate in another randomized trial (NCT01872962) at the same time receive the protocol chemotherapy. Induction chemotherapy regimens are as follows: gemcitabine (1000 mg/m² d1,8) plus cisplatin (80mg/m² d1) or docetaxel (75mg/m² d1) plus cisplatin (75mg/m², total dose average to d1-d3) every 3 weeks for three cycles. concurrent chemotherapy include cisplatin (100mg/m² d1 or 80mg/m², total dose average to d1-d3) every 3 weeks for three cycles. Our primary endpoint is loco-regional recurrence-free survival (LRRFS) rate. Secondary end points include overall survival (OS) rate, distant metastasis-free survival (DMFS) rate, constituent ratio of local and regional recurrence pattern, toxic effects, quality of life scores and dosimetric parameters of IMRT planning. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

6. Conditions and Keywords

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

Nasopharyngeal Neoplasms

Keywords

Nasopharyngeal carcinoma, Intensity modulated radiotherapy, Clinical target volume, Clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

386 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individualized CTV

Arm Type

Experimental

Arm Description

Arm Title

Traditional CTV

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

IMRT using individualized CTV

Intervention Description

Intensity modulated radiotherapy (IMRT) using individualized CTV based on disease extension risk atlas and computer-aided delineation is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.

Intervention Type

Radiation

Intervention Name(s)

IMRT using traditional CTV

Intervention Description

Intensity modulated radiotherapy(IMRT) using traditional CTV is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and cisplatin (induction chemotherapy)

Other Intervention Name(s)

Gemcitabine and cisplatin (GP)

Intervention Description

Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who participate in another randomized trial (NCT01872962) at the same time receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Docetaxel and cisplatin (induction chemotherapy)

Other Intervention Name(s)

Docetaxel and cisplatin (TP)

Intervention Description

Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who haven't participated in other trials receive docetaxel (75 mg/m² d1) and cisplatin (75mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles before radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Cisplatin 100mg/m² concurrent chemotherapy

Other Intervention Name(s)

DDP 100mg/m²

Intervention Description

Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC. Patients who participate another clinical trial (NCT01872962) at the same time receive cisplatin (100mg/m² d1) every 3 weeks for 3 cycles concurrently with radiotherapy.

Intervention Type

Drug

Intervention Name(s)

Cisplatin 80mg/m² concurrent chemotherapy

Other Intervention Name(s)

DDP 80mg/m²

Intervention Description

Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC.Patients who haven't participated in other trials receive cisplatin (80mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles concurrently with radiotherapy.

Primary Outcome Measure Information:

Title

Local-regional recurrence-free survival rate

Description

Local-regional recurrence-free survival is calculated from the date of randomization to the date of local or regional recurrence, whichever is first.

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Overall survival rate

Description

Overall survival is calculated from the date of randomization to the date of death from any cause.

Time Frame

3-year

Title

Distant metastasis-free survival rate

Description

Distant metastasis-free survival is calculated from the date of randomization to the date of the first distant metastasis.

Time Frame

3-year

Title

Constituent ratio of local and regional recurrence pattern

Description

Constituent ratio of local and regional recurrence pattern is defined as the proportion of in-field,marginal and out-field recurrence.

Time Frame

3-year

Title

Number of participants with adverse events

Description

Incidence of acute and late toxicity

Time Frame

3-year

Title

Quality of life score measured by EORTC QLQ-C30

Description

Quality of life is measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30).

Time Frame

3-year

Title

Quality of life score measured by EORTC H&N35

Description

Quality of life is measured by European Organization for Research and Treatment of Cancer Quality of Life Head and Neck Questionnaire (EORTC QLQ-H&N35).

Time Frame

3-year

Title

Target volumes' dose coverage and doses irradiated to organs at risk

Description

For example, relative volume of planning target volume (PTV) receive 110%,95%,93% of the prescription doses;max dose or dose receive by 1% volume of brainstem; et,al.

Time Frame

3-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). Tumor staged as T1-4N0-3M0 (according to the 7th AJCC edition), based upon the following minimum diagnostic workup within 4 weeks prior to registration:(1) history/physical examination;(2)chest X-ray, PA and lateral OR chest CT OR PET/CT;(3) pre-treatment magnetic resonance imaging (MRI) of nasopharynx and neck, pre-treatment MRI must be done at Sun Yat-sen University Cancer Center;(4) sonography OR CT of upper abdoman OR PET/CT;(5) Bone scan OR PET/CT. Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. Adequate bone marrow function based upon the complete blood count within 2 weeks prior to registration: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. Adequate hepatic function within 2 weeks prior to registration: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN. Adequate renal function within 2 weeks prior to registration: serum creatinine ≤ 133 umol/L or calculated creatinine clearance ≥ 60 ml/min. Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study. Patients must be informed of the investigational nature of this study and sign a written informed consent. Exclusion Criteria: Age > 65 or < 18. Prior malignancy except adequately treated basal cell or squamous cell skin cancer outside head and neck region, in situ cervical cancer. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except fine needle aspiration biopsy) to primary tumor or nodes. Hearing loss due to sensorineural deafness（except tumor induced conductive hearing loss). Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), emotional disturbance, untreated active infectious disease, and acquired immune deficiency syndrome. Prior allergic reaction to the study drugs involved in this protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ying Sun, Ph.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21296855

Citation

Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.

Results Reference

background

PubMed Identifier

20643517

Citation

Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.

Results Reference

background

PubMed Identifier

19362784

Citation

Lin S, Pan J, Han L, Zhang X, Liao X, Lu JJ. Nasopharyngeal carcinoma treated with reduced-volume intensity-modulated radiation therapy: report on the 3-year outcome of a prospective series. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1071-8. doi: 10.1016/j.ijrobp.2008.12.015. Epub 2009 Apr 11.

Results Reference

background

PubMed Identifier

12007936

Citation

Lee N, Xia P, Quivey JM, Sultanem K, Poon I, Akazawa C, Akazawa P, Weinberg V, Fu KK. Intensity-modulated radiotherapy in the treatment of nasopharyngeal carcinoma: an update of the UCSF experience. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):12-22. doi: 10.1016/s0360-3016(02)02724-4.

Results Reference

background

PubMed Identifier

15590175

Citation

Kam MK, Teo PM, Chau RM, Cheung KY, Choi PH, Kwan WH, Leung SF, Zee B, Chan AT. Treatment of nasopharyngeal carcinoma with intensity-modulated radiotherapy: the Hong Kong experience. Int J Radiat Oncol Biol Phys. 2004 Dec 1;60(5):1440-50. doi: 10.1016/j.ijrobp.2004.05.022.

Results Reference

background

PubMed Identifier

19386431

Citation

Tham IW, Hee SW, Yeo RM, Salleh PB, Lee J, Tan TW, Fong KW, Chua ET, Wee JT. Treatment of nasopharyngeal carcinoma using intensity-modulated radiotherapy-the national cancer centre singapore experience. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1481-6. doi: 10.1016/j.ijrobp.2009.01.018. Epub 2009 Apr 20.

Results Reference

background

PubMed Identifier

11172942

Citation

Hunt MA, Zelefsky MJ, Wolden S, Chui CS, LoSasso T, Rosenzweig K, Chong L, Spirou SV, Fromme L, Lumley M, Amols HA, Ling CC, Leibel SA. Treatment planning and delivery of intensity-modulated radiation therapy for primary nasopharynx cancer. Int J Radiat Oncol Biol Phys. 2001 Mar 1;49(3):623-32. doi: 10.1016/s0360-3016(00)01389-4.

Results Reference

background

PubMed Identifier

15936155

Citation

Wolden SL, Chen WC, Pfister DG, Kraus DH, Berry SL, Zelefsky MJ. Intensity-modulated radiation therapy (IMRT) for nasopharynx cancer: update of the Memorial Sloan-Kettering experience. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):57-62. doi: 10.1016/j.ijrobp.2005.03.057. Epub 2005 Jun 2.

Results Reference

background

PubMed Identifier

17971582

Citation

Kam MK, Leung SF, Zee B, Chau RM, Suen JJ, Mo F, Lai M, Ho R, Cheung KY, Yu BK, Chiu SK, Choi PH, Teo PM, Kwan WH, Chan AT. Prospective randomized study of intensity-modulated radiotherapy on salivary gland function in early-stage nasopharyngeal carcinoma patients. J Clin Oncol. 2007 Nov 1;25(31):4873-9. doi: 10.1200/JCO.2007.11.5501.

Results Reference

background

PubMed Identifier

19251378

Citation

Liang SB, Sun Y, Liu LZ, Chen Y, Chen L, Mao YP, Tang LL, Tian L, Lin AH, Liu MZ, Li L, Ma J. Extension of local disease in nasopharyngeal carcinoma detected by magnetic resonance imaging: improvement of clinical target volume delineation. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):742-50. doi: 10.1016/j.ijrobp.2008.11.053. Epub 2009 Feb 27.

Results Reference

background

PubMed Identifier

19117352

Citation

Tang L, Mao Y, Liu L, Liang S, Chen Y, Sun Y, Liao X, Lin A, Liu M, Li L, Ma J. The volume to be irradiated during selective neck irradiation in nasopharyngeal carcinoma: analysis of the spread patterns in lymph nodes by magnetic resonance imaging. Cancer. 2009 Feb 1;115(3):680-8. doi: 10.1002/cncr.24049.

Results Reference

background

PubMed Identifier

16377415

Citation

Baujat B, Audry H, Bourhis J, Chan AT, Onat H, Chua DT, Kwong DL, Al-Sarraf M, Chi KH, Hareyama M, Leung SF, Thephamongkhol K, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients. Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):47-56. doi: 10.1016/j.ijrobp.2005.06.037.

Results Reference

background

Citation

Edge SB, Byrd DR, Compton CC, et al: AJCC Cancer Staging Manual (ed 7th). New York, Springer, 2010

Results Reference

background

Citation

Chow SC, Shao J, Wang H: Sample Size Calculations in Clinical Research. New York, Marcel Dekker, 2003

Results Reference

background

Citation

Freedman J, Furberg C, DeMets D: Fundamentals of clinical trials. New York, Springer-Verlag, 1998

Results Reference

background

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Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma

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