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Individualized Elective Neck Irradiation Based on MRI in NPC Patients (NPC-CTVn)

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ClinicalTrials.gov Identifier: NCT02642107
Recruitment Status : Active, not recruiting
First Posted : December 30, 2015
Last Update Posted : May 31, 2018
Sponsor:
Collaborators:
First People's Hoapital of Foshan
Guilin Medical College Affiliated Hospital
Information provided by (Responsible Party):
Ling-Long Tang, Sun Yat-sen University

Brief Summary:
Currently, most protocols of nasopharyngeal carcinoma(NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V, and also to the supraclavicular lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node metastasis in NPC followed an orderly manner. Retropharyngeal lymph nodes (RLNs) and Level II LNs were the most commonly involved, followed by Level III and Level V LNs, Level IV LNs, and SCF LNs, and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck lymph node metastases to experience neck failure after elective irradiation to levels II, III and VA. It also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs.Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC with N0-N1.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Elective neck irradiation Radiation: Whole neck irradiation Phase 3

Detailed Description:
Currently, most protocols of nasopharyngeal carcinoma(NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V, and also to the supraclavicular lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node metastasis in NPC followed an orderly manner. Retropharyngeal lymph nodes (RLNs) and Level II LNs were the most commonly involved, followed by Level III and Level V LNs, Level IV LNs, and SCF LNs, and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck lymph node metastases to experience neck failure after elective irradiation to levels II, III and VA. It also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs.Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC with N0-N1.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Multicenter Randomized Phase 3 Trial of Individualized Elective Neck Irradiation Based on MRI in Patients With Nasopharyngeal Carcinoma
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2018
Estimated Study Completion Date : May 2021

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Arm Intervention/treatment
Experimental: Elective neck irradiation
Whole neck irradiation is given in the positive neck. Elective neck irradiation of Level II,III,Va lymph node area is given in negative neck, and Level IV,Vb and Supraclavicular fossa lymph node area were not irradiated in negative neck.
Radiation: Elective neck irradiation
Whole neck irradiation is given in the positive neck. Elective neck irradiation of Level II,III,Va lymph node area is given in negative neck, and Level IV,Vb and Supraclavicular fossa lymph node area were not irradiated in negative neck.

Active Comparator: Whole neck irradiation
Whole neck irradiation is given regardless of the positive or negative neck.
Radiation: Whole neck irradiation
Whole neck irradiation is given regardless of negative neck or positive neck




Primary Outcome Measures :
  1. Nodal relapse-free survival [ Time Frame: 3 year ]
    The nodal relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse. There differences will be compared between treatment arms using the log-rank test.


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 3 year ]
    Acute and late toxicity will be documented according to RTOG/EORTC System and the CTCAE(Common Terminology Criteria for Adverse Events). The accumulate toxicity rate will estimated using Kaplan-Meier method for each arm from the date of randomization to the date of late toxicity. The differences will be compared between treatment arms using the log-rank test.

  2. Overall survival [ Time Frame: 3 year ]
    The overall survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to death from any cause. Their differences will be compared between treatment arms using the log-rank test.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
  • Tumor staged as T1-4N0/N1(according to the 7th AJCC edition staging system)
  • No evidence of distant metastasis (M0)
  • Performance status: KPS > 70
  • Written informed consent

Exclusion Criteria:

  • Age > 65 or < 18
  • Treatment with palliative intent
  • Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
  • 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 diagnostic) to primary tumor or nodes
  • 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), and emotional disturbance

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642107


Locations
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
First People's Hoapital of Foshan
Guilin Medical College Affiliated Hospital
Investigators
Principal Investigator: Linglong Tang, M.D.,PhD Sun sat-sen University Cancer Center

Responsible Party: Ling-Long Tang, associated professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02642107     History of Changes
Other Study ID Numbers: 5010-2015-05
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ling-Long Tang, Sun Yat-sen University:
nasopharyngeal carcinoma
elective neck irradiation

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases