CNG Staging Compared With 8th UICC of NPC for Treatment Decision-marking and Selection of Chemotherapy and Radiotherapy
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|ClinicalTrials.gov Identifier: NCT03529279|
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: CNG Chemotherapy Drug: NCCN Chemotherapy Radiation: CNG Radiation Radiation: NCCN Radiation||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1324 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CNG Staging Compared With UICC Eighth Staging of Nasopharyngeal Carcinoma for Treatment Decision-marking and Selection of Chemotherapy and Radiotherapy： a Multicenter, Open Label, Randomized Controlled, Non-inferiority Clinical Trial|
|Estimated Study Start Date :||June 12, 2018|
|Estimated Primary Completion Date :||June 12, 2026|
|Estimated Study Completion Date :||June 12, 2026|
Experimental: Experimental Group
The patients in the Experimental Group are allocated to receive CNG staging and CNG chemotherapy strategy and CNG radiation strategy
Drug: CNG Chemotherapy
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.
Other Name: Chemotherapy strategy for experimental group
Radiation: CNG 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.
Other Name: Radiation for experimental group
Active Comparator: Controlled Group
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
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.
Other Name: Chemotherapy strategy for controlled group
Radiation: NCCN 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.
Other Name: Radiation for controlled group
- Overall Survival (OS) [ Time Frame: From the date of randomization until the date of death, assessed up to 60 months ]5-year overall survival
- Quality of life [ Time Frame: From the date of radiotherapy begin, every week during radiotherapy, assessed up to 60 months ]The standard scores assessed by EORTC QOL scale decreased by more than 10 points
- Recurrence free survival (RFS) [ Time Frame: From the date of randomization until the date of first recurrence, assessed up to 60 months ]5-year recurrence free survival
- Distant metastasis free survival (DMFS) [ Time Frame: From the date of randomization until the date of first distant metastasis, assessed up to 60 months ]5-year distant metastasis free survival
- Disease specific survival (DSS) [ Time Frame: From the date of randomization until the date of death from tumor, assessed up to 60 months ]5-year disease specific survival
- Complete remission (CR) [ Time Frame: From the date of randomization, 3 months after radiotherapy ]all the target lesions disappeared, no new lesions appeared, and the tumor markers were normal, and maintained for at least 4 weeks, according to RECIST
- Incidence of side effects associated with tumor therapy [ Time Frame: From the date of randomization up to 60 months ]according to NCI CTC 4.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529279
|Contact: Yun-fei Xia, M.Demail@example.com|
|Contact: Chen Chen, M.Dfirstname.lastname@example.org|
|Principal Investigator:||Yun-fei Xia, M.D||Sun Yat-sen University|