Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-08 @ 11:08 AM
Study NCT ID:
NCT02994069
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2016-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cisplatin + Radiation in SCCHN and Correlation With Oxidative Stress Markers
Sponsor:
Susanne Arnold
Organization:
Study Overview
Official Title:
Comparison of Every 3 Week Versus Weekly Cisplatin Concurrent With Radiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN) and Correlation With Oxidative Stress Markers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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:
Patients will receive standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin and either weekly cisplatin or every 3-week cisplatin in locally advanced SCCHN. The relationship between cisplatin toxicity and the level of reactive oxygen species generated by the drug in subjects with squamous cell carcinoma of the head and neck treated on this trial.
Detailed Description:
Patients will first be designated as either: a) Cohort 1 (locally advanced non-nasopharyngeal SCCHN that is unresectable) OR b) Cohort 2 (resected and at high risk of recurrence with at least one of the following criteria: extracapsular nodal extension, or invasive cancer at the primary tumor resection margin (positive margin), lymphovascular invasion or perineural invasion, pT3 or pT4 primary, or the presence of multilevel nodal disease. Subjects will then be randomized to receive either Arm 1 or Arm 2 cisplatin.
Radiation and Cisplatin will be given concurrently and should start on the same day, ±1 day. Radiation will continue without interruption whenever possible.
Treatment will consist of standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin, as determined by treating radiation oncologist. Patients will be randomized to receive cisplatin at 100 mg/m2 every 3 weeks (3 doses) during radiation versus cisplatin at 40 mg/m2 once weekly (7 doses) during radiation. This will provide similar cumulative doses of cisplatin in all arms of the study.IMRT will be delivered in 30-35 fractions over 6-7 weeks, 5 fractions weekly.
In the absence of treatment delays due to adverse event(s), treatment will continue for 7 weeks or until one of the following criteria applies:
Disease progression,Intercurrent illness that prevents further administration of treatment, Unacceptable adverse event(s), Patient decides to withdraw from the study, or General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Patients will be followed for 2 years after completion of chemoradiation or until death, whichever occurs first, for toxicity and PFS.
Radiation and Cisplatin will be given concurrently and should start on the same day, ±1 day. Radiation will continue without interruption whenever possible.
Treatment will consist of standard of care radiation therapy to the primary tumor of the head and neck and involved nodal metastasis and draining nodal basin, as determined by treating radiation oncologist. Patients will be randomized to receive cisplatin at 100 mg/m2 every 3 weeks (3 doses) during radiation versus cisplatin at 40 mg/m2 once weekly (7 doses) during radiation. This will provide similar cumulative doses of cisplatin in all arms of the study.IMRT will be delivered in 30-35 fractions over 6-7 weeks, 5 fractions weekly.
In the absence of treatment delays due to adverse event(s), treatment will continue for 7 weeks or until one of the following criteria applies:
Disease progression,Intercurrent illness that prevents further administration of treatment, Unacceptable adverse event(s), Patient decides to withdraw from the study, or General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.
Patients will be followed for 2 years after completion of chemoradiation or until death, whichever occurs first, for toxicity and PFS.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: