Optimization of Cervical Nodal CTV for Early and Medium Stage NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Optimization of Cervical Nodal Clinical Tumor Volume for Early and Medium Stage Nasopharyngeal Carcinoma: a Multicenter Non-inferior Randomized Controlled Phase III Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05145660
• Other study ID #: NCC-2021C-257
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: August 31, 2027

Study information

• Verified date: September 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Junlin Yi, doctor
• Phone: 13661217998
• Email: yijunlin1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current radiotherapy guidelines and consensus statements uniformly recommend elective region irradiation (ERI) as the standard strategy for nasopharyngeal carcinoma (NPC). However, given the scarcity of skip-metastasis, the improved assessment accuracy of nodal involvement, and the striking advancements in chemotherapy for NPC, a one-fits-all delineation scheme for clinical target volumes for the nodal region (CTVn) may not be appropriate anymore, and modifications of the CTVn delineation strategy may be warranted. Involved site irradiation (ISI) covering merely the initially involved nodal site and potential extranodal extension has been confirmed to be as effective as ERI with decreased radiation-related toxicities in some malignancies, but has not yet been investigated in NPC. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of ISI with conventional ERI in NPC patients with a limited nodal burden.

Description:

ISRT-NPC is a prospective, multicenter, open-label, noninferiority, phase III randomized controlled trial. A total of 488 patients will be randomly assigned in a 1:1 ratio to receive ISI or ERI. Randomization will be stratified by institution and N stage. Generally, in the ISI group, the high-risk CTV1 (dose: 60 Gy) includes a 1-cm expansion of the positive LN as well as the VIIa and the retrostyloid space above the bilateral transverse process of the atlantoaxial spine (C1), regardless of N status. The low-risk CTV2 (Dose: 50 Gy) covers the cervical nodal region with a 3-cm caudal expansion below the transverse process of C1 for N0 disease and a 3-cm expansion below the positive LN for positive LNs (at least covering the level II).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 414
• Est. completion date: August 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

1. Age between 18 and 75 years;

2. Karnofsky performance status (KPS) score = 70;

3. Pathologically confirmed World Health Organization (WHO) type II-III NPC;

4. TNM stage I-III (T1-3N0-2M0) according to the 8th American Joint Committee on Cancer / Union for International Cancer Control (AJCC/UICC) staging system with a maximum diameter (MAD) of cervical involved LNs = 3 cm, namely LB-LN;

5. Available baseline nasopharynx and neck computed tomography (CT) or magnetic resonance imaging (MRI) (strongly advocated) data (including functional MRI sequences) and measurable tumor lesions;

6. All procedures for defining the tumor burden completed within 4 weeks of registration;

7. Survival expectancy of at least 6 months;

8. Normal marrow and organ function: hemoglobin = 120 g/L, WBCs = 4 × 109 /L, platelets = 100 × 109 /L; liver and kidney function-related indicators within 1.25*the normal upper limit;

9. Patient willingness to comply with the protocol;

10. Patient willingness and ability to provide an informed consent form.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Radiation:
• intensity-modulated radiotherapy (IMRT) with reduced-volume
PGTVnx: 69.9Gy/2.12Gy/33f GTVrpn: 69.9Gy/2.12Gy/33f GTVnd: 69.9Gy/2.12Gy/33f GTVnd-suspicious: 60.06Gy/1.82Gy/33f PTV1: 60.06Gy/1.82Gy/33f PTV2: 50.96Gy/1.82Gy/28f

Drug:
• Chemotherapy
Concurrent cisplatin (100 mg/m², d1-3, Q3w, maximum to three cycles); The application of induction chemotherapy and consolidation chemotherapy is dependent on the physician's discretion.

Locations

Country	Name	City	State
China	National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jun-Lin Yi, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional-recurrence-free survival	measured from the registration to the documented regional recurrence	3-year
Secondary	Overall survival	measured from registration to documented death from any cause or last follow-up	3-year
Secondary	Distant metastasis-free survival	measured from registration to documented distant metastasis or death from any cause	3-year
Secondary	Progression-free survival	measured from registration to documented locoregional recurrence or distant metastasis or death from any cause	3-year
Secondary	Number of Participants with acute and late radiation-related toxicities	Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 4.0 scale. Acute radiation-related toxicities include dermatitis, mucositis, dry mouth, dysphagia, trismus, and subcutaneous soft tissue. Late radiation toxicities are assessed according to the Radiation Therapy Oncology Group (RTOG) and European Organisation for Research and Treatment of Cancer (EORTC) late radiation morbidity scoring scheme, including skin, neck tissue damage, hypothyroidism, dry mouth, dysphagia, trismus, and other adverse events.	8-year