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Phase Ⅲ Trial of Adjuvant Chemotherapy in Patients With N2-3 Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03321539
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hai-Qiang Mai,MD,PhD, Sun Yat-sen University

Brief Summary:
To see the effect if a combination of concurrent chemoradiotherapy followed by different adjuvant chemotherapy in treating patients with N2-3 nasopharyngeal carcinoma(NPC).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: CCRT+GP Drug: CCRT+PF Phase 3

Detailed Description:
This phase Ⅲ trial is studying how well radiation therapy and chemotherapy work in treating patients with newly diagnosed N2-3 nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil or cisplatin and gemcitabine, work in different ways (concurrent chemoradiotherapy followed by different adjuvant chemotherapy) to stop the growth of tumor cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Cancer Center of Guangzhou Medical University
  2. The First Affiliated Hospital/School of Clinical Medicine of Guangdong Pharmaceutical University
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ⅲ Trial of Concurrent Chemoradiotherapy Followed by Adjuvant Chemotherapy (GP Versus PF) in Patients With N2-3 Nasopharyngeal Carcinoma
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CCRT+GP
Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during radiotherapy followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21days for three cycles
Drug: CCRT+GP
Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21 days for three cycles 4 weeks after radiotherapy.
Other Name: Adjuvant GP

Active Comparator: CCRT+PF
Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles
Drug: CCRT+PF
Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles 4 weeks after radiotherapy.
Other Name: Adjuvant PF




Primary Outcome Measures :
  1. Progress-free survival(PFS) [ Time Frame: 3 years ]
    Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.


Secondary Outcome Measures :
  1. Overall survival(OS) [ Time Frame: 3 years ]
    The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

  2. Locoregional failure-free survival(LRRFS) [ Time Frame: 3 years ]
    The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

  3. Distant metastasis-free survival(DMFS) [ Time Frame: 3 years ]
    The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

  4. Overall response rate [ Time Frame: 16 weeks after completion of concurrent chemoradiotherapy ]
    Tumour response was classified according to RECIST, version 1.1

  5. Incidence of acute and late toxicity [ Time Frame: 3 years ]
    Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme



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

Inclusion Criteria:

  • Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
  • Original clinical staged as any T、N2-3M0(according to the American Joint Committee on Cancer(AJCC) 7th edition)
  • No evidence of distant metastasis (M0).
  • Age 18-65 years old.
  • ECOG Performance status less or equal to 1.
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age <18 or >65 years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

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): NCT03321539


Contacts
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Contact: Sun Rui, MD,PhD +862087343380 sunrui@sysucc.org.cn

Locations
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China, Guangdong
Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Dong-Ping Chen, MD    +862066673626    chen_dpgz@163.com   
The First Affiliated Hospital of Guangdong Pharmaceutical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xi-Cheng Wang, MD    +862061321397    13902400598@126.com   
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Hai-Qiang Mai, MD,PhD    +862087343643    maihq@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Hai-Qiang Mai, MD,PhD Sun Yat-sen University

Publications of Results:
Other Publications:

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Responsible Party: Hai-Qiang Mai,MD,PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03321539     History of Changes
Other Study ID Numbers: 2017-FXY-077
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hai-Qiang Mai,MD,PhD, Sun Yat-sen University:
Nasopharyngeal carcinoma;adjuvant chemotherapy

Additional relevant MeSH terms:
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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
Carcinoma
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents