CNG Staging Compared With 8th UICC of NPC for Treatment Decision-marking and Selection of Chemotherapy and Radiotherapy

NCT03529279 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: B2018-030-01
• Study Type: interventional
• Target: 1,324
• Locations: 0 countries
• Sites: N/A

Brief Summary

Due to the increase of tumor control rate and survival rate in era of IMRT, the role of the seventh edition of UICC/AJCC staging system in predicting prognosis is becoming weaker and inaccurate. Therefore, we put forward a new staging for the clinical staging of NPC in the era of IMRT without changing the current T, N, M staging definition of the 7th of the UICC/AJCC staging system. We call this new stage "Cooperative Nasopharyngeal Carcinoma Group" stage, namely CNG stage. In CNG stage, the clinical stages were reduced to three stages, namely, CNG I stage includes T1-3N0-1M0 and T1-2N2M0, CNG II stage includes T3N2M0, T4N0-2M0 and TanyN3M0, CNG III stage includes TanyNanyM1. For CNG I stage, the IMRT alone is sufficient. If EBV-DNA copies is more than 0 copy/ml, concurrent chemoradiotherapy will be given. For CNG II stage, patients can benefit from combined radiotherapy and chemotherapy. For CNG III stage, patients are recommended for systemic chemotherapy plus local radiotherapy (primary focus, neck drainage area and distant metastasis). This year, UICC/AJCC has proposed an eighth edition of NPC staging system. The eighth version is mainly changed in the definition and refinement of the anatomic location compared with the seventh edition. This is different from our new CNG staging concept. Therefore, CNG staging and its treatment strategy was used as the experimental group, and the eighth edition of UICC/AJCC staging with NCCN guiding treatment was used as the control group. The open and randomized controlled clinical study was conducted. The purpose of this study was to evaluate in the era of IMRT, CNG staging can be better than UICC/AJCC eighth clinical staging for treatment decision-marking and selection of chemotherapy and radiotherapy, and differentiating differences in prognosis in each clinical stage. The survival results based on CNG staging and its treatment are not inferior to the survival results of the NCCN guide therapy based on the eighth edition UICC/AJCC staging, to avoid chemotherapy for some of the patients, and to improve the outcome of metastatic patients.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  5-year overall survival

  From the date of randomization until the date of death, assessed up to 60 months

Secondary Outcomes (6)

• Quality of life

  From the date of radiotherapy begin, every week during radiotherapy, assessed up to 60 months

• Recurrence free survival (RFS)

  From the date of randomization until the date of first recurrence, assessed up to 60 months

• Distant metastasis free survival (DMFS)

  From the date of randomization until the date of first distant metastasis, assessed up to 60 months

• Disease specific survival (DSS)

  From the date of randomization until the date of death from tumor, assessed up to 60 months

• Complete remission (CR)

  From the date of randomization, 3 months after radiotherapy

Study Arms (2)

Experimental Group

EXPERIMENTAL

The patients in the Experimental Group are allocated to receive CNG staging and CNG chemotherapy strategy and CNG radiation strategy

Drug: CNG Chemotherapy; Radiation: CNG Radiation

Controlled Group

ACTIVE COMPARATOR

The patients in the Controlled Group are allocated to receive the eighth edition of UICC/AJCC staging and NCCN chemotherapy strategy and NCCN radiation strategy

Drug: NCCN Chemotherapy; Radiation: NCCN Radiation

Interventions

CNG Chemotherapy DRUG

CNG I, IMRT plus oral adjuvant chemotherapy, if EBV-DNA \> 0,according to CNG II. CNG II, IMRT + concurrent chemotherapy + oral adjuvant chemotherapy. CNG III, systemic chemotherapy, plus IMRT. Chemotherapy strategy: Concurrent chemotherapy, 5-Fu + nedaplatin (cisplatin), every 28 days; 5-Fu 500mg/m2. D, civ d1-d5, nedaplatin (cisplatin) 80mg (70mg) /m2. D, D1. Systemic chemotherapy, 5-Fu + nedaplatin (cisplatin), every 60 days; 5-Fu (100 - 200 mg/m2. D) civ for 30 days, nedaplatin (cisplatin) 80mg (70mg) /m2. D, D1,D28. Aim to achieve CR in imaging.Oral adjuvant chemotherapy, tegafon (400 mg, QID) and Calcium Folinate Tablets (30 mg, QID). Oral 10 days and stop 20 days, 3 months/course. After 6 courses, oral 10 days and stop 50 days, half year/course, 6-7 courses, lasted for 5 years.

Also known as: Chemotherapy strategy for experimental group

Experimental Group

NCCN Chemotherapy DRUG

UICC I, IMRT. UICC II-IVA, concurrent chemoradiotherapy ± adjuvant chemotherapy, or induced chemotherapy plus concurrent chemoradiotherapy. UICC IVB, platinum based combined chemotherapy, followed by IMRT or concurrent chemoradiotherapy, or concurrent chemoradiotherapy. Chemotherapy strategy: Concurrent cisplatin with or without cisplatin plus 5-Fu or carboplatin combined with 5-Fu adjuvant chemotherapy; The combined chemotherapy regimen of IVB stage patients may choose cisplatin or carboplatin plus docetaxel or paclitaxel, cisplatin plus 5-Fu, carboplatin and cetuximab, cisplatin plus gemcitabine, and gemcitabine. The combination of vinorelbine and cisplatin, carboplatin, paclitaxel, docetaxel, 5-Fu, methotrexate, gemcitabine and capecitabine can be used in combination with radiotherapy.

Also known as: Chemotherapy strategy for controlled group

Controlled Group

CNG Radiation RADIATION

IMRT technique. GTV was given to 6810cGy, CTV1 was given to 6000cGy, and CTV2 was given to 4800-5400cGy. 30 fractions, daily, QW1-5. CT-SIM or MR-CIM was evaluated every 10 fractions. If CR for CNG I and II patients at 10 fractions, radiotherapy were given 25 fractions, that was, GTV was given to 5675cGy, CTV1 was given 5000cGy, and CTV2 was given 4000-4500cGy, 25 fractions, daily, QW1-5. If tumor reduced less than 50% at 20 fractions, GTV was modified according to tumor size at 20 fractions. The modified GTV was given 300cGy/F×5 after 25 fractions; the original CTV1 and CTV2 were unchanged, that is, GTV was given to 5675cGy/25Fr+1500cGy/5Fr and CTV1 was given to 6000cGy/30Fr, CTV2 was given 4800-5400cGy/30Fr.

Also known as: Radiation for experimental group

Experimental Group

NCCN Radiation RADIATION

IMRT technique. When IMRT alone, GTV were given (1) 66Gy (2.2Gy/Fr) to 70-70.2 Gy (1.8-2.0 Gy/Fr), QW1-5, 6-7 weeks; (2) 69.96 Gy (2.12 Gy/Fr), 6-7 weeks; CTV1-2 were given 44-50 (2.0 Gy/Fr) to 54-63 (1.8 Gy/Fr). When combined with chemotherapy, GTV were given 70-70.2 Gy (1.8-2.0 Gy/Fr), QW1-5, 7 weeks; CTV1-2 were given 44-50 Gy (2 Gy/Fr) to 54-63 Gy (1.8 Gy/Fr). When palliative radiotherapy, 50Gy/20Fr; 37.5 Gy/15Fr (if tolerable, increases 5 fractions to 50Gy); 30Gy/10Fr, 30Gy/5Fr, 2 fractions per week, interval more than 3 days; 44.4Gy/12Fr was divided into 3 cycles, 2 fractions a day, 6 hours of interval, 2 consecutive days and 3-4 weeks between two cycles. After second cycles, the treatment plan must completely avoid the irradiation of the spinal cord.

Also known as: Radiation for controlled group

Controlled Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed and previously untreated nasopharyngeal carcinoma
• Non T1N0M0 patient according to UICC/AJCC seventh edition staging system
• Age ≥ 18 years and \< 65 years
• Karnofsky performance status (KPS) score ≥ 70
• Adequate normal organ function
• No history of other malignant tumors
• No serious mental disorder (schizophrenia, delusion of victimization, manic depression, and drug induced anxiety)
• No AIDS, active pulmonary tuberculosis and other serious immunodeficiency diseases
• No communication barrier, can answer the question
• Sign informed consent under voluntary circumstances, complete treatment and follow up as required

You may not qualify if:

• Poor compliance
• Investigators consider as inappropriate for enrolling into this study

Sponsors & Collaborators

• Sun Yat-sen University: lead

Related Publications (1)

• Zheng S, Liu Y, He Z, He S, Huang Z, Luo W, Han F, Tao Y, Chen C, Ouyang P, Chen L, Huang Y, Zhou G, Li W, Liu Q, Chen C, Xia Y. CNG (Collaborative Nasopharyngeal Carcinoma Group) stage: Improved prognostic stratification of nasopharyngeal carcinoma and association with Epstein-Barr virus DNA in the intensity-modulated radiation therapy era. Radiother Oncol. 2025 Sep;210:111051. doi: 10.1016/j.radonc.2025.111051. Epub 2025 Jul 19.

  PMID: 40692079 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Yun-fei Xia, M.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, M.D

CONTACT

86-13602805461; xiayf@sysucc.org.cn

Chen Chen, M.D

CONTACT

86-13570487011; chenchen@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 6, 2018
• First Posted: May 18, 2018
• Study Start: June 12, 2018
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026
• Last Updated: May 18, 2018

Record last verified: 2018-05