Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine

November 9, 2021 updated by: Sun Pharmaceutical Industries Limited

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

The purpose of this study is to compare the incidence of stomatitis when treating with amifostine before radiation treatment.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cytofos group A
Amifostine 500 mg sc, qod, 3 times per week Radiation treatment 30 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
Drug: Amifostine
500 mg sc, qod, 3 times per week
Radiation: Amifostine
500mg rinsing wash, qod, 3 times per week
Experimental: Cytofos group B
Amifostine 500mg rinsing wash, qod, 3 times per week Radiation treatment 5 min after amifostine treatment, 1.8-2.0 Gy/day × 30-35 times
Drug: Amifostine
500 mg sc, qod, 3 times per week
Radiation: Amifostine
500mg rinsing wash, qod, 3 times per week
Active Comparator: Control group
Radiation treatment 1.8-2.0 Gy/day × 30-35 times
Drug: Amifostine
500 mg sc, qod, 3 times per week
Radiation: Amifostine
500mg rinsing wash, qod, 3 times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and duration of oral mucositis
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Investigators

  • Principal Investigator: Wang ge, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUN-2011-DP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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