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

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

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).

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Department of radiation oncology, Fujian cancer hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who met the inclusion criteria and did not meet the exclusion criteria of our center.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
regional recurrence-free survival (RRFS)	The duration of time to regional failure were calculated from the start of treatment to the dates of recurrence.	60 months
level IB nodal recurrence-free survival	The duration of time to level Ib recurrence were calculated from the start of treatment to the date of Ievel Ib recurrence.	60 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local recurrence-free survival (LRFS)	LRFS was calculated from the start of treatment to the dates of local recurrence.	60 months
distant metastasis-free survival (DMFS)	DMFS was calculated from the start of treatment to the dates of distant metastasis.	60 months
Overall survival	OS was calculated from the date of randomization to death from any cause.	60 months

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 7, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: NPC006.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No