Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529279
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yun-fei Xia, Sun Yat-sen University

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.


Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: CNG Chemotherapy Drug: NCCN Chemotherapy Radiation: CNG Radiation Radiation: NCCN Radiation Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From the date of randomization until the date of death, assessed up to 60 months ]
    5-year overall survival


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529279


Contacts
Layout table for location contacts
Contact: Yun-fei Xia, M.D 86-13602805461 xiayf@sysucc.org.cn
Contact: Chen Chen, M.D 86-13570487011 chenchen@sysucc.org.cn

Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Yun-fei Xia, M.D Sun Yat-sen University
Layout table for additonal information
Responsible Party: Yun-fei Xia, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03529279    
Other Study ID Numbers: B2018-030-01
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Nasopharyngeal 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