WithdrawnNCT01288625Updated Nov 17, 2021

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

A Phase 4 interventional study of Amifostine and Amifostine in Oral Mucositis and Stomatitis, sponsored by Sun Pharmaceutical Industries Limited. Withdrawn. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-17.

Sponsored by Sun Pharmaceutical Industries Limited · Phase 4, Interventional, and Supportive care

Why this study was withdrawn

There were IP availability issues due to which the study could not be started.

Phase: Phase 4
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Conditions studied

Oral Mucositis
Stomatitis

Browse trials for

Keywords

Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Sun Pharmaceutical Industries Limited is the lead sponsor of 58 studies on the registry; 5 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

18-70 years old, male or female
Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis
Postoperative patients should receive radiation treatment in 12 weeks
ECOG \<2
Expected lifetime ≥6months
No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.)
Not involved in other clinical trials
Sign ICF

Exclusion criteria

Exclusion Criteria:

ECOG >2
Suffered other cancers in the past 5 years
Received amifostine treatment in the past 4 weeks
Unable to complete treatment or sign ICF because of medical or physical reasons

Study design

Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

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 · Radiation: Amifostine
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 · Radiation: Amifostine
Active comparator
Control group
Radiation treatment 1.8-2.0 Gy/day × 30-35 times
Drug: Amifostine · Radiation: Amifostine

Interventions

DrugAmifostine
500 mg sc, qod, 3 times per week
RadiationAmifostine
500mg rinsing wash, qod, 3 times per week

What researchers measure

Primary outcomes

Incidence and duration of oral mucositis
Time frame: 3 months

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01288625
Lead sponsor: Sun Pharmaceutical Industries Limited
Responsible party: Sponsor
First posted: Feb 2, 2011
Last update: Nov 17, 2021

Study contacts

Wang ge

principal investigator · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Head and Neck Neoplasms→

Other studies from this sponsor

Sun Pharmaceutical Industries Limited

Start the discussion