Individualized Elective Neck Irradiation Based on MRI in NPC Patients (NPC-CTVn)

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Whole neck irradiation; Radiation: Elective neck irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02642107

5010-2015-05

Details and patient eligibility

About

Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Full description

Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Enrollment: 446 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; with unilateral or bilateral uninvolved neck; aged between 18 and 65 years; Karnofsky performance-status score > 70; adequate haematological function, with a leucocyte count > 4 × 109/L, haemoglobin > 90 g/L, and a thrombocyte count > 100×109/L.

The exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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446 participants in 2 patient groups

Elective neck irradiation

Experimental group

Description:

Whole neck irradiation is given in the involved neck. Elective neck irradiation of Level II,III and Va lymph node area is given in the uninvolved neck, and Level IV and Vb lymph node area were not irradiated in the uninvolved neck.

Treatment:

Radiation: Elective neck irradiation

Whole neck irradiation

Active Comparator group

Description:

Whole neck irradiation is given regardless of the involved or uninvolved neck.

Treatment:

Radiation: Whole neck irradiation