Trial | NCT02636231  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    endostatin ...

  • Study Participants

    96
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.
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 Started
Nov 30
2015
Primary Completion
Mar 31
2020
Study Completion
Dec 31
2021
Anticipated
Last Update
Feb 03
2021

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.

IMRT and concurrent Endostar Active Comparator

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.

IMRT alone Experimental

IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.

Criteria 

Inclusion Criteria:

Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
No evidence of distant metastasis
More than 1 year from the end of the first course of radiotherapy
Male, or female not in the phase of lactating or pregnancy
ECOG 0-2
Aged 18-70 years old
WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
Written informed consort signed

Exclusion Criteria:

Only regionally recurrence
Evidence of distant metastasis
Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
Severe, active co-morbidity
Prior anti-tumor treatment after diagnosis of local recurrence
MRI was not performed 3 months after the first course of radiotherapy
Abnormal function of heart, brain and lungs, etc
Lactation or pregnancy
Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
No Results Posted