Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International Guidelines

F

Fujian Provincial Cancer Hospital

Status and phase

Not yet enrolling
Phase 3

Conditions

Nasopharyngeal Carcinoma

Treatments

Radiation: level Ib-covering IMRT
Radiation: level Ib-sparing IMRT

Study type

Interventional

Funder types

Other

Identifiers

NCT05519956
NPC008.1

Details and patient eligibility

About

Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with ECE, and/or had a MAD of greater than 2cm in level II.

Full description

Currently, nasopharyngeal carcinoma (NPC) patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II will be recommended to receive level Ib-covering IMRT according to the International Guidelines. Our previous study, which retrospectively analyzed a cohort of 390 patients, indicated that it should be safe and feasible for patients who only had at least one of the above two radiological features. Thus, the investigators conduct this non-inferior phase 3, randomized trial to further determine the feasibility of sparing level Ib in patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.

Enrollment

398 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • newly diagnosed, non-metastatic nasopharyngeal carcinoma histologically confirmed by biopsy;
  • the following conditions: ① involvement of level II LNs with extracapsular extension(ECE); ② level II LNs involvement with maximum nodal axial diameter (MAD) greater than 2 cm;
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

Exclusion criteria

  • level Ib involvement with positive pathological results;
  • submandibular glands (SMGs) involvement;
  • involvement of structures that drain to level Ib as the first echelon site (the oral cavity, anterior half of nasal cavity involvement);
  • previous malignancy or other concomitant malignant disease.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

398 participants in 2 patient groups

level Ib-covering IMRT
Active Comparator group
Description:
Patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II.
Treatment:
Radiation: level Ib-covering IMRT
level Ib-sparing IMRT
Experimental group
Description:
Patients who had level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 2cm in level II
Treatment:
Radiation: level Ib-sparing IMRT

Trial contacts and locations

0

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Central trial contact

Qiaojuan Guo, DR; Shaojun Lin, DR

Data sourced from clinicaltrials.gov

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