Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Brief Title

Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Official Title

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

Brief Summary

      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.

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

Secondary Outcome

 Number of participants with severe acute toxicities as assessed by CTCAE v3.0

Condition

Nasopharyngeal Carcinoma

Intervention

Endostatins

Study Arms / Comparison Groups

 IMRT and concurrent Endostar

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

November 2015

Completion Date

December 2019

Primary Completion Date

December 2019

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Fei Han, M.D., Ph.D., 8620-87343030, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02636231

Organization ID

NPC201501

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Collaborators

 JiangXi Province Tumor Hospital

Study Sponsor

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

Verification Date

October 2018