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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04745741
• Other study ID #: NPC006.1
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2021
• Source: Fujian Cancer Hospital
• Contact: Shaojun Lin, DR
• Phone: 13860603879
• Email: linshaojun[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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: ? level IB metastasis, ? involvement of the submandibular gland, ? involvement of structures that drain to level Ib as the first echelon site ( the oral cavity, anterior half of nasal cavity involvement) ? 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.)? 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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	Department of radiation oncology, Fujian cancer hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

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