A Phase II Trial of PG2 in Patients With Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma Under Concurrent Chemoradiotherapy
NCT ID: NCT01720563
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
17 participants
INTERVENTIONAL
2012-12-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Placebo
Placebo
500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Treatment
Astragalus polysaccharides 500 mg
Astragalus polysaccharides 500 mg
PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Interventions
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Astragalus polysaccharides 500 mg
PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Placebo
500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Primary tumor site in the head and neck area
* Stage III or IV disease
* Measurable locoregional disease and no distant metastasis
* No prior cancer treatment
* 20-70 years old
* KPS ≧ 70
* Adequate bone marrow, liver, and renal function
* Fed with gastric tubes but without intestinal malabsorption or obstruction
* Not pregnancy and use a reliable contraceptive method during the study
* Signed informed consent
* Willing and able to complete quality of life questionnaires
Exclusion Criteria
* Serious concomitant illness that might be aggravated by chemotherapy
* Active cardiac disease preceding the entry into the study
* Severe uncontrolled hypertension
* Uncontrolled infection
* History of other malignancy
* Pregnant or breast feeding
* Receiving other concomitant chemotherapy, radiotherapy or any other anticancer treatment
* Mental status not suitable for clinical trials
* Intestinal obstruction or malabsorption.
20 Years
70 Years
ALL
No
Sponsors
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PhytoHealth Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Hung-Ming HM Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Other Identifiers
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PH-CP021
Identifier Type: -
Identifier Source: org_study_id
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