Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma (IMRT)

October 22, 2019 updated by: Fei Han, Sun Yat-sen University

Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

Study Type

Interventional

Enrollment (Anticipated)

346

Phase

  • 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 Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • WangHanYu
        • Contact:

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;

    2.No evidence of distant metastasis

    3.More than 1 year from the end of the first course of radiotherapy

    4.Male, or female not in the phase of lactating or pregnancy

    5.ECOG 0-2

    6.Aged 18-70 years old

    7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L

    8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits

    9.Written informed consort signed

Exclusion Criteria:

  1. Only regionally recurrence
  2. Evidence of distant metastasis
  3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
  4. Severe, active co-morbidity
  5. Prior anti-tumor treatment after diagnosis of local recurrence
  6. MRI was not performed 3 months after the first course of radiotherapy
  7. Abnormal function of heart, brain and lungs, etc
  8. Lactation or pregnancy
  9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence

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
Intervention / Treatment
Active Comparator: IMRT and concurrent cisplatin
IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction
Drug: Cisplatin
cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction
Radiation: IMRT
Radiation: IMRT IMRT is to give 60Gy in 27 fraction
Experimental: IMRT alone
IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction
Radiation: IMRT
Radiation: IMRT IMRT is to give 60Gy in 27 fraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: From the beginning the IMRT to 3 year after the end of IMRT
From the beginning the IMRT to 3 year after the end of IMRT

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema
Time Frame: From 3 months after the end of IMRT to 1 year after the end of IMRT
From 3 months after the end of IMRT to 1 year after the end of IMRT
Number of participants with severe acute toxicities as assessed by CTCAE v3.0
Time Frame: From the beginning of IMRT to 3 months after the end of IMRT
From the beginning of IMRT to 3 months after the end of IMRT

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

Wuhan University
Tongji Hospital
Hunan Province Tumor Hospital
Second Affiliated Hospital of Nanchang University
Fujian Province Tumor Hospital
Hainan Cancer Hospital
JiangXi Province Tumor Hospital
SiChuan Province Tumor Hospital
YuNan Province Tumor Hospital
GuiZhou Province Tumor Hospital
First Hospital of FoShan City

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 (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2019-070-01

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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