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Alliance A221101

Trial

Clinical Trial Title

Alliance A221101

Trial Status

Open to Enrollment

Start Date

April 16, 2013

Location

Trial Type

Cancer (Oncology)

Specific Condition

Fatigue in Glioblastoma Patients

Description

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with Glioblastoma Multiforme

Eligibility Criteria

 

  • Age ≥ 18 years
  •  Glioblastoma multiforme who are clinically stable and have completed radiation therapy >21 days and ≤ 24 months prior to enrollment. 
  •  ≥6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, see appendix III Question 3)
  • Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for Glioblastoma
  • Ability to complete questionnaire(s) by themselves or with assistance
  • ECOG Performance Status (PS) of 0, 1, 2 or 3
  • Provide informed written consent

If you are in group 1, you will take a dose of the armodafinil (150 mg) by mouth, every day in the morning. You will take this every day for 8 weeks.

you will take a dose of the armodafinil (150 mg) by mouth, every day in the morning. You will take this every day for 8 weeks.

If you are in group 2, you will take a dose of the placebo pill (inactive ingredient) by mouth, every day in the morning. You will take this every day for 8 weeks.

you will take a dose of the placebo pill (inactive ingredient) by mouth, every day in the morning. You will take this every day for 8 weeks.

If you are in group 3, you will take a dose of the armodafinil (250 mg) by mouth, every day in the morning. You will take this every day for 8 weeks.

you will take a dose of the armodafinil (250 mg) by mouth, every day in the morning. You will take this every day for 8 weeks.

IRB Number

Legacy IRB

Notes

Sponsored by: Alliance for Clinical Trials in Oncology (Alliance)

• Cancer and Leukemia Group B (CALGB)

• North Central Cancer Treatment Group (NCCTG)

• American College of Surgeons Oncology Group (ACOSOG

Principal Investigator Name

Regan Look, MD

Contact Name

Legacy Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Last Updated: Wednesday, September 18, 2013 01:24:41 PM