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Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

U

University of Chinese Academy Sciences

Status and phase

Unknown
Phase 3

Conditions

Stage IVC Nasopharyngeal Carcinoma
Effects of Chemotherapy

Treatments

Drug: Gemcitabine and cisplatin
Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01915134
ZhejaingCH-npc-03

Details and patient eligibility

About

The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Full description

To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).

Enrollment

362 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis,at least one measurable metastatic lesions,ECOG PS 0-1,Electrocardiogram (ecg) no special abnormal,comply with the test requirements, cooperate with regular follow-up.

Exclusion criteria

  • To give local treatment,clinical severe infection(>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

362 participants in 2 patient groups

EGP group
Experimental group
Description:
the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy
Treatment:
Drug: Recombinant Human Endostatin plus gemcitabine and cisplatin
GP group
Active Comparator group
Description:
the group of participants who undergoing only Gemcitabine and cisplatin chemotherapy
Treatment:
Drug: Gemcitabine and cisplatin

Trial contacts and locations

1

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Central trial contact

Xiaozhong Chen; Bin Li

Data sourced from clinicaltrials.gov

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