Individualized Elective Neck Irradiation Based on MRI in NPC Patients (NPC-CTVn)
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ClinicalTrials.gov Identifier: NCT02642107 |
Recruitment Status :
Completed
First Posted : December 30, 2015
Last Update Posted : November 5, 2021
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Condition or disease | Intervention/treatment | Phase |
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Nasopharyngeal Carcinoma | Radiation: Elective neck irradiation Radiation: Whole neck irradiation | Phase 3 |
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 |
Actual Study Completion Date : | May 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Elective neck irradiation
Whole neck irradiation is given in the involved neck. Elective neck irradiation of Level II,III and Va lymph node area is given in the uninvolved neck, and Level IV and Vb lymph node area were not irradiated in the uninvolved neck.
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Radiation: Elective neck irradiation
Whole neck irradiation is given in the involved neck. Elective neck irradiation of Level II,III and Va lymph node area is given in the uninvolved neck, and Level IV and Vb lymph node area were not irradiated in the uninvolved neck. |
Active Comparator: Whole neck irradiation
Whole neck irradiation is given regardless of the involved or uninvolved neck.
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Radiation: Whole neck irradiation
Whole neck irradiation is given regardless of the involved or uninvolved neck. |
- Regional relapse-free survival [ Time Frame: 3 year ]The regional 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 or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
- Radiation-related toxicity [ Time Frame: Within 1 month after radiotherapy for acute toxicity; long term for late toxicity ]Acute and late toxicity will be documented according to RTOG/EORTC System and the CTCAE(Common Terminology Criteria for Adverse Events). Toxicity will be summarized using descriptive statistics.
- 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.
- Local relapse-free survival [ Time Frame: 3 year ]The local relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented local relapse or death from any cause. Their differences will be compared between treatment arms using the log-rank test.
- Distant metastasis-free survival [ Time Frame: 3 year ]The distant metastasis-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to documented distant metastasis or death from any cause. Their differences will be compared between treatment arms using the log-rank test.
- Patient's quality-of-life: global health status [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on global health status suggest better health.
- Patient's quality-of-life: physical functioning [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the functioning scales suggest better function.
- Patient's quality-of-life: role functioning [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the functioning scales suggest better function.
- Patient's quality-of-life: emotional functioning [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the functioning scales suggest better function.
- Patient's quality-of-life: cognitive functioning [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the functioning scales suggest better function.
- Patient's quality-of-life: social functioning [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the functioning scales suggest better function.
- Patient's quality-of-life: fatigue [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: nausea and vomiting [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: pain [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: dyspnoea [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: insomnia [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: appetite loss [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: constipation [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: diarrhoea [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: financial difficulties [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Core 30 items (QLQ-C30) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: pain [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: swallowing [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: sense problems [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: speech problems [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: trouble social eating [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: trouble social contact [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: less sexuality [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: teeth [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: open mouth [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: dry mouth [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: sticky saliva [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: coughing [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: felt ill [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: pain killers [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: nutrition supplement [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: feeding tube [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: weight loss [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
- Patient's quality-of-life: weight gain [ Time Frame: 3 year ]European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck 35 items (QLQ-H&N35) version 1.0 questionnaires will be used to assess quality-of-life. All items pointing to this domain are averaged and then transformed to a scale of 0-100 according to the EORTC scoring manual. Higher scores on the symptom scales indicate more severe symptoms.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; with unilateral or bilateral uninvolved neck; aged between 18 and 65 years; Karnofsky performance-status score > 70; adequate haematological function, with a leucocyte count > 4 × 109/L, haemoglobin > 90 g/L, and a thrombocyte count > 100×109/L.
The exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.
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
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 |
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 |
Other Study ID Numbers: |
5010-2015-05 |
First Posted: | December 30, 2015 Key Record Dates |
Last Update Posted: | November 5, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
nasopharyngeal carcinoma elective neck irradiation upper neck irradiation whole neck irradiation |
Carcinoma Nasopharyngeal Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Nasopharyngeal Neoplasms Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |