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Evaluating the Rationality of the International Guideline About Selective Coverage of Level Ib in CTV With NPC

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ClinicalTrials.gov Identifier: NCT04745741
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

Study Description
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Brief Summary:
The purpose of this study was to evaluate its rationality in real-world data and provide clinical evidence for the refinement of nodal CTV delineation in nasopharyngeal carcinoma(NPC).

Condition or disease Intervention/treatment
Nasopharyngeal Carcinoma Radiation: IB-positive group

Detailed Description:
Intensity-modulated radiation therapy (IMRT) has gradually replaced two-dimensional radiation therapy as it offers improved target conformity. Xerostomia is still the most common side effect of radiotherapy in patients with NPC treated with IMRT. Most stimulated saliva is secreted by the parotid glands (PGs), while the submandibular glands (SMGs) produce most of the unstimulated saliva and mucins, which may influence the degree of a dry mouth sensation.There are still differences in the understanding of nasopharyngeal cancer experts at home and abroad on the delineation of clinical target volumes., suitable criteria for elective irradiation of neck level Ib need to be re-evaluated.Therefore, we conducted a retrospective study to assess the feasibility of recommendation to level Ib in the International Guideline for Delineation of Clinical Target Volumes.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Rationality of the International Guideline's Recommendations Regarding Selective Coverage of Level Ib in Node Clinical Target Volume With Nasopharyngeal Carcinoma : Results From a Real-world Series
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021

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Groups and Cohorts
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Group/Cohort Intervention/treatment
IB-positive group
Patients with level IB metastasis and histologically confirmed positive by biopsy.
 Radiation: IB-positive group
The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.


Outcome Measures
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Primary Outcome Measures :
  1. regional recurrence-free survival (RRFS) [ Time Frame: 60 months ]
    The duration of time to regional failure were calculated from the start of treatment to the dates of recurrence.

  2. level IB nodal recurrence-free survival [ Time Frame: 60 months ]
    The duration of time to level Ib recurrence were calculated from the start of treatment to the date of Ievel Ib recurrence.


Secondary Outcome Measures :
  1. local recurrence-free survival (LRFS) [ Time Frame: 60 months ]
    LRFS was calculated from the start of treatment to the dates of local recurrence.

  2. distant metastasis-free survival (DMFS) [ Time Frame: 60 months ]
    DMFS was calculated from the start of treatment to the dates of distant metastasis.

  3. Overall survival [ Time Frame: 60 months ]
    OS was calculated from the date of randomization to death from any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who met the inclusion criteria and did not meet the exclusion criteria of our center.
Criteria

Inclusion Criteria:

  1. histologically confirmed NPC by biopsy (clearly recorded in the pathology report or medical history) ;
  2. no evidence of distant metastasis at initial diagnosis and receiving radical IMRT in our center
  3. the following conditions: ① level IB metastasis, ② involvement of the submandibular gland, ③ involvement of structures that drain to level Ib as the first echelon site ( the oral cavity, anterior half of nasal cavity involvement) ④ involvement of level II LNs with extracapsular extension（because the judgment of extracapsular invasion is greatly influenced by subjective factors, this study only include patients who had high grade ENE(G2/G3 as demonstrated in our previous study: Oral Oncol. 2019 Dec;99:104438.)⑤ level II nodal involvement with maximum nodal axial diameter greater than 2 cm.
  4. all patients who were treated at Lin Shaojun's attending group from June 2005 to December 2012.
  5. presence of complete baseline magnetic resonance imaging data of the nasopharyngeal skull base and neck and treated in our center at initial diagnosis .

Exclusion Criteria:

  1. disease progression during IMRT;
  2. fail to obtain tumor efficacy evaluation information in the medical records of the research center;
  3. previous malignancy or other concomitant malignant disease;
  4. receiving blind treatment in clinical research.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04745741


Contacts
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Contact: Shaojun Lin, DR 13860603879 linshaojun@yeah.net
Contact: Qiaojuan Guo, DR 15080013157 guoqiaojuan@163.com

Locations
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China, Fujian
Department of radiation oncology, Fujian cancer hospital
Fuzhou, Fujian, China, 350014
Sponsors and Collaborators
Fujian Cancer Hospital
Investigators
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Study Chair: Shaojun Lin, DR Fujian Cancer Hospital
More Information
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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT04745741    
Other Study ID Numbers: NPC006.1
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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