Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-09 @ 10:12 PM
Study NCT ID:
NCT01903018
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2013-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess Radiation Induced Mucositis in Patients of Head and Neck Cancer Administered Chemo-Radiation With or Without P276-00
Sponsor:
Piramal Enterprises Limited
Organization:
Study Overview
Official Title:
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects With Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation With or Without P276-00
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Clinical Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Detailed Description:
A Multicenter, Phase II/III Study to Assess Radiation Induced Mucositis in Subjects with Locally Advanced Squamous Cell Carcinoma of the Head and Neck Administered Cisplatin and Radiation with or without P276-00
The Phase II component will be a single arm, open label, multicenter study to assess RIM in subjects with locally advanced SCCHN treated with P276-00 in combination with radiation therapy and cisplatin. '
The Phase III component will be a randomized, assessor blinded, multicenter, two-arm study to compare the time to onset of WHO Grade ≥ 3 RIM in subjects with locally advanced SCCHN (OC, OP, HP, and L) who are receiving definitive CRT for treatment of their malignancy. Subjects receiving definitive CRT will receive weekly intravenous cisplatin administered during radiation.
The Phase II component will be a single arm, open label, multicenter study to assess RIM in subjects with locally advanced SCCHN treated with P276-00 in combination with radiation therapy and cisplatin. '
The Phase III component will be a randomized, assessor blinded, multicenter, two-arm study to compare the time to onset of WHO Grade ≥ 3 RIM in subjects with locally advanced SCCHN (OC, OP, HP, and L) who are receiving definitive CRT for treatment of their malignancy. Subjects receiving definitive CRT will receive weekly intravenous cisplatin administered during radiation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: