Endostar for Locally Recurrent Nasopharyngeal Carcinoma

January 31, 2021 updated by: Fei Han, Sun Yat-sen University

A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients

The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients.

The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.

Study Type

Interventional

Enrollment (Anticipated)

96

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
      • Foshan, Guangdong, China, 528000
        • First People's Hospital of Foshan
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510000
        • Cancer Center of Guangzhou Medical University
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
    • Jiangxi
      • GanZhou, Jiangxi, China, 341000
        • The First Hospital of Gannan Medical University
      • Ganzhou, Jiangxi, China, 341000
        • The Affiliated Ganzhou Hospital of Nanchang University
      • NanChang, Jiangxi, China, 330006
        • Second Affiliated Hospital of Nanchang University
      • NanChang, Jiangxi, China, 330029
        • JiangXi Province Tumor 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

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 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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: IMRT and concurrent Endostar

IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.

IMRT is to give GTV 60Gy in 27 fractions.
Drug: Endostatins
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
Other Names:
  • Endostar
Radiation: IMRT
IMRT is to give GTV 60Gy in 27 fractions.
EXPERIMENTAL: IMRT alone
IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.
Radiation: IMRT
IMRT is to give GTV 60Gy in 27 fractions.

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

First People's Hospital of Foshan
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Second Affiliated Hospital of Nanchang University
The Affiliated Ganzhou Hospital of Nanchang University
JiangXi Province Tumor Hospital
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
The First Hospital of Gannan Medical University

Investigators

  • Principal Investigator: Fei Han, M.D., Ph.D., China: Ethics Committee

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)

November 1, 2015

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (ESTIMATE)

December 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 3, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC201501

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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