Clinical trial NCT04745741: Evaluating the Rationality of the International Guideline About Selective Coverage of Level Ib in CTV With NPC
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2021-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who met the inclusion criteria and did not meet the exclusion criteria of our center.

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).

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.

Eligibility 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.

Primary outcomes:
measure: regional recurrence-free survival (RRFS)
timeFrame: 60 months
measure: level IB nodal recurrence-free survival
timeFrame: 60 months
Secondary outcomes:
measure: local recurrence-free survival (LRFS)
timeFrame: 60 months
measure: distant metastasis-free survival (DMFS)
timeFrame: 60 months
measure: Overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of radiation oncology, Fujian cancer hospital
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: Shaojun Lin, DR
role: STUDY_CHAIR
References: