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Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine


Phase 4
18 Years
70 Years
Not Enrolling
Both
Oral Mucositis, Stomatitis

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Trial Information

Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine


Inclusion Criteria:



1. 18-70 years old, male or female

2. Primary treatment of phase I-IVA head and neck cancer patients, identified by
histological and pathological diagnosis

3. Postoperative patients should receive radiation treatment in 12 weeks

4. ECOG <2

5. Expected lifetime ≥6months

6. No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.)

7. Not involved in other clinical trials

8. Sign ICF

Exclusion Criteria:

1. ECOG >2

2. Suffered other cancers in the past 5 years

3. Received amifostine treatment in the past 4 weeks

4. Unable to complete treatment or sign ICF because of medical or physical reasons

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Incidence and duration of oral mucositis

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Wang ge

Investigator Role:

Principal Investigator

Investigator Affiliation:

Daping Hospital

Authority:

China: Institutional Review Board

Study ID:

SUN-2011-DP

NCT ID:

NCT01288625

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Oral Mucositis
  • Stomatitis
  • Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

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