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

May 10, 2018 updated by: Wei Jiang

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Baise, Guangxi, China
        • Affiliated Hospital of Youjiang Medical University for Nationalities
      • Guigang, Guangxi, China
        • Guigang People's Hospital
      • Guilin, Guangxi, China
        • Guangxi Naxishan Hospital
      • Liuzhou, Guangxi, China
        • Liuzhou people's Hospital
      • Nanning, Guangxi, China
        • Nanning Monority Hospital
      • Wuzhou, Guangxi, China
        • Wuzhou Red Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • No.
Drug: Cisplatin
Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.
Other Names:
  • No.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 years
Overall survival is from randomization to death of any cause or last follow-up.
3 years
Locoregional Failure-free Survival
Time Frame: 3 years
Locoregional failure-free survival is from randomization to locoregional progression.
3 years
Distant Failure-free Survival
Time Frame: 3 years
Distant failure-free survival is from randomization to first distant metastasis.
3 years
Number of Participants with Adverse Events
Time Frame: 3 years
Incidence of acute and late toxicity
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wei Jiang

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wei Jiang, Ph.D., Guilin Medical University Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GLMU-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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