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A Phase II Double-blind and Randomized Trial Comparing Concurrent Chemoradiotherapy Plus PG2 Injection Versus Concurrent Chemoradiotherapy Plus Placebo in Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma


Phase 2
20 Years
70 Years
Open (Enrolling)
Both
Cancer-related Fatigue

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Trial Information

A Phase II Double-blind and Randomized Trial Comparing Concurrent Chemoradiotherapy Plus PG2 Injection Versus Concurrent Chemoradiotherapy Plus Placebo in Advanced Pharyngeal or Laryngeal Squamous Cell Carcinoma


Inclusion Criteria:



- Histological confirmation of squamous cell carcinoma

- 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:

- Decompensated liver function

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Fatigue status by Brief Fatigue Inventory (BFI)

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Hung-Ming HM Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chang Gung Memorial Hospital

Authority:

Taiwan : Food and Drug Administration

Study ID:

PH-CP021

NCT ID:

NCT01720563

Start Date:

December 2012

Completion Date:

October 2014

Related Keywords:

  • Cancer-Related Fatigue
  • Cancer-related fatigue
  • astragalus polysaccharides
  • concurrent chemoradiotherapy
  • squamous cell carcinoma of head and neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Fatigue
  • Laryngeal Neoplasms

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