Last updated: September 27, 2021
Sponsor: Sun Yat-sen University
Overall Status: Completed
Phase
3
Condition
Carcinoma
Nasopharyngeal Cancer
Treatment
N/AClinical Study ID
NCT01528618
GEM20110714
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically proven NPC diagnosis
- Elder than 18 years old are inclusive
- Recurrence or metastatic nasopharyngeal carcinoma with evidence of unsuitable forlocal treatment
- Amenable to regular follow-up
- Subjects with at least one measurable lesion (Tumor lesions that are situated in apreviously irradiated area could not be considered measurable).
- Performance status: 0-1(ECOG)
- WBC > 4.0X109/L, PLT > 100X109/L, with normal hepatic function(AST, ALT < 2.5 x upperlimit of normal , and bilirubin < 1.5 x upper limit of normal), with normal renalfunction (Creatinine < 1.5 x upper limit of normal)
- No chemotherapy or radical radiotherapy received within 6 months prior to enrollment
- Life expectancy over twelve weeks
- Signed and dated informed consent before the start of specific protocol procedures
- Ability to comply with trial requirements.
Exclusion
Exclusion Criteria:
- Patient suitable for local treatment (eg. radiotherapy)
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)
- Patient with central nervous system metastasis
- Patient life threatening medical condition
- Pregnant or breast-feeding patients. Women of childbearing potential must have anegative pregnancy test performed within 7 days of the start of treatment. Both menand women enrolled in this trial must use adequate barrier birth control measuresduring the course of the trial and two weeks after the completion of trial.
- Performance status ≥ 2
- With a pre-existing peripheral neuropathy (National Cancer Institute Common ToxicityCriteria for Adverse Events [NCI CTC] grade ≥ 2)
- Serious concurrent illness
- Previous or concurrent cancer that is distinct in primary site or histology from thecancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basalcell carcinoma, superficial bladder tumors[Ta, Tis & T1] or any cancer curativelytreated > 3 years prior to study entry.
- Patient refusing participation
Study Design
Total Participants: 362
Study Start date:
February 21, 2012
Estimated Completion Date:
December 20, 2020
Study Description
Connect with a study center
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong 510060
ChinaSite Not Available
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