Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

February 9, 2017 updated by: Ling Guo, Sun Yat-sen University

Phase II Randomized Trial Comparing Paclitaxel Combined With DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Nasopharyngeal carcinoma is one of the most common malignancies in South China. Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Concurrent chemoradiation has become a standard treatment for locally advanced stage III-IVb nasopharyngeal carcinoma. However, The recommended single-agent DDP concurrent chemotherapy regimen for high-risk patients (IVa-IVb period) to improve the efficacy was not significant. Paclitaxel combined with platinum in the same period of chemotherapy regimen has been widely used in head and neck cancer, cervical cancer, esophageal squamous cell carcinoma and lung cancer and other tumors, a number of studies have shown that it has good tolerance and efficacy. And a number of previous studies have shown that paclitaxel combined with platinum chemotherapy in the same period of head and neck cancer or nasopharyngeal cancer in multiple phase II clinical trials to achieve encouraging results. Based on the above background and basis, for the high risk (IVa-IVb) nasopharyngeal carcinoma treatment, the applicant intends to carry out the first IMRT + paclitaxel + DDP concurrent chemotherapy compared with DDP single drug concurrent chemotherapy regimen Pharyngeal cancer in a prospective randomized controlled phase Ⅱ clinical trial for paclitaxel + DDP dual-chemotherapy regimen for the treatment of high-risk nasopharyngeal carcinoma to provide evidence-based basis. (IVa-IVb) nasopharyngeal carcinoma (NPC), and to provide a high-level evidence-based evidence-based approach to the treatment of nasopharyngeal carcinoma at high risk (stage IVa-IVb). The results of this study will be used in international guidelines to optimize high- Treatment of cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Phase 2

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

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

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with newly histologically confirmed non-keratinizing carcinoma.
  2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.
  3. Original clinical staged as IVa-IVb（according to the 7th AJCC edition）.
  4. Male and no pregnant female
  5. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.
  6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
  7. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
  8. With normal renal function test (Creatinine ≤ 1.5×ULN)
  9. Written informed consent.

Exclusion Criteria:

  1. Patients have evidence of relapse or distant metastasis Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
  2. Receiving radiotherapy or chemotherapy previously
  3. The presence of uncontrolled life-threatening illness
  4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

  5. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease.

    Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).

  6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
  7. Concurrent systemic steroid therapy
  8. HIV positive
  9. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cisplatin
Cisplatin combine with IMRT
Drug: Cisplatin
Cisplatin 100mg / m2 , D1,D22,D43 of RT, a total of 3 courses.
Other Names:
  • DDP
EXPERIMENTAL: Paclitaxel
Paclitaxel plus Cisplatin combine with IMRT
Drug: Paclitaxel
Paclitaxel 135mg / m2 D1, DDP 20mg / m2 D1-4, D1,D29 of RT, a total of 2 courses.
Other Names:
  • TAXOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year progress free survival(PFS)
Time Frame: 3 years
PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival(OS)
Time Frame: 2 years ,3 years and 5 years
the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups.
2 years ,3 years and 5 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

February 4, 2017

Primary Completion (ANTICIPATED)

December 1, 2025

Study Completion (ANTICIPATED)

June 1, 2027

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 7, 2017

First Posted (ESTIMATE)

February 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308-2016-02-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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