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Induction Chemotherapy Followed by IMRT With or Without Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT02434614
Recruitment Status : Unknown
Verified May 2018 by Wei Jiang, Guilin Medical University, China.
Recruitment status was:  Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
LiuZhou People's Hospital
Guigang People's Hospital
Affiliated Hospital of Youjiang Medical University for Nationalities
Nanning Monority Hospital
Information provided by (Responsible Party):
Wei Jiang, Guilin Medical University, China

Study Description
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Brief Summary:
Several prospective randomized trials have demonstrated that concurrent chemoradiotherapy was superior to radiotherapy alone in the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). Based on these evidences, concurrent chemoradiotherapy (CCRT) with/without sequential chemotherapy has become the standard care for locoregionally advanced NPC. However, most of these evidences of standard treatment for locoregionally advanced NPC were based on the two-dimensional conventional radiotherapy (2DCRT). As the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, more retrospective studies compared the IMRT alone vs. IMRT plus concurrent chemotherapy, and reported that concurrent chemotherapy failed to improve survival rates for patients with locoregionally advanced disease, but increased the severity of acute toxicities. People started to reconsider the role of CCRT. Therefore, we propose this randomized phase III non-inferiority study to reassess the efficacy and contribution of concurrent chemotherapy in locoregionally advanced NPC during IMRT era.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Docetaxel,Cisplatin,Fluorouracil Radiation: Intensity-modulated radiation therapy (IMRT) Drug: Cisplatin Phase 3

Detailed Description:
Patients with with previously untreated non-metastatic newly histologically-confirmed non-keratinizing III-IVb NPC (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy followed by IMRT alone (investigational group) or induction chemotherapy followed by IMRT plus concurrent chemotherapy (control group). During induction chemotherapy, patients in both groups receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks. During radiotherapy, patients in investigational group received IMRT alone and patients in control group received IMRT, concurrently with weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. The primary endpoint is failure-free survival(FFS). Secondary clinical endpoints include overall survival (OS), locoregional failure-free survival (LRFFS), distant failure-free survival (DFFS) rates and toxic effects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Non-inferiority Study of Induction Chemotherapy Followed by IMRT Alone Versus Induction Chemotherapy Followed by IMRT Plus Concurrent Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
Study Start Date : March 2015
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Induction CT+IMRT alone
Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone
 Drug: Docetaxel,Cisplatin,Fluorouracil
Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks.
Other Name: No.

Radiation: Intensity-modulated radiation therapy (IMRT)
IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.
Other Name: No.
Active Comparator: Induction CT+IMRT Combined Concurrent CT
Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy
 Drug: Docetaxel,Cisplatin,Fluorouracil
Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks.
Other Name: No.

Radiation: Intensity-modulated radiation therapy (IMRT)
IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.
Other Name: No.

Drug: Cisplatin
Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.
Other Name: No.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 3 years ]
    Progression-free survival is to first disease progression [local recurrence and/or distant metastasis] or death from any cause.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
    Overall survival is from randomization to death of any cause or last follow-up.

  2. Locoregional Failure-free Survival [ Time Frame: 3 years ]
    Locoregional failure-free survival is from randomization to locoregional progression.

  3. Distant Failure-free Survival [ Time Frame: 3 years ]
    Distant failure-free survival is from randomization to first distant metastasis.

  4. Number of Participants with Adverse Events [ Time Frame: 3 years ]
    Incidence of acute and late toxicity


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 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 WHO histologically type); Tumor staged as III-IVb (according to the 7th AJCC edition); No pregnant female; Age between 18-70; Normal complete blood count level (hemoglobin >10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL); Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase < 2.5 times higher than upper limit); Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Without radiotherapy or chemotherapy; Patients must give signed informed consent.

Exclusion Criteria:

Disease progression in the process of the treatment; The presence of uncontrolled life-threatening illness; History of previous radiotherapy or chemotherapy; Pregnancy or lactation.

Contacts and Locations
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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): NCT02434614


Locations
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China, Guangxi
Affiliated Hospital of Youjiang Medical University for Nationalities
Baise, Guangxi, China
Guigang People's Hospital
Guigang, Guangxi, China
Guangxi Naxishan Hospital
Guilin, Guangxi, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
Nanning Monority Hospital
Nanning, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Sponsors and Collaborators
Wei Jiang
Wuzhou Red Cross Hospital
Guangxi Naxishan Hospital
LiuZhou People's Hospital
Guigang People's Hospital
Affiliated Hospital of Youjiang Medical University for Nationalities
Nanning Monority Hospital
Investigators
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Study Director: Wei Jiang, Ph.D. Guilin Medical University Affiliated Hospital
More Information
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Responsible Party: Wei Jiang, Ph.D., Guilin Medical University, China
ClinicalTrials.gov Identifier: NCT02434614    
Other Study ID Numbers: GLMU-01
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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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
 Cisplatin
Docetaxel
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs