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Quality-of-Life Assessment for Squamous Cell Carcinoma

Kaiser Permanente-Lone Tree, Lone Tree, CO
Squamous Cell Carcinoma+6 More ConditionsQuality-of-Life Assessment - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a lower dose of a chemotherapy drug, given more often, is as effective as a higher dose of the drug given less often, in treating patients with head and neck cancer.

Eligible Conditions
  • Laryngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Oropharyngeal Cancer
  • Squamous Cell Carcinoma of Unknown Primary
  • Advanced Hypopharyngeal Squamous Cell Carcinoma
  • Head and Neck Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2 & 3

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Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Up to 9 years

Month 6
Hearing loss
Year 9
Overall Survival (OS) (Phase III)
Year 9
Progression-free survival (PFS)
Day 180
Incidence of acute toxicity
Incidence of acute toxicity (Phase II)
Incidence of acute toxicity (Phase III)
Up to 9 years
Incidence of late toxicity
Locoregional Failure Rates

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Arm IV (low-dose cisplatin, radiation therapy)
1 of 4
Arm III (high-dose cisplatin, radiation therapy)
1 of 4
ARM I (high-dose cisplatin, radiation therapy)
1 of 4
Arm II (low-dose cisplatin, radiation therapy)
1 of 4

Experimental Treatment

464 Total Participants · 4 Treatment Groups

Primary Treatment: Quality-of-Life Assessment · No Placebo Group · Phase 2 & 3

Arm IV (low-dose cisplatin, radiation therapy)Experimental Group · 4 Interventions: Cisplatin, Quality-of-Life Assessment, Radiation Therapy, Questionnaire Administration · Intervention Types: Drug, Other, Radiation, Other
Arm III (high-dose cisplatin, radiation therapy)Experimental Group · 4 Interventions: Cisplatin, Quality-of-Life Assessment, Radiation Therapy, Questionnaire Administration · Intervention Types: Drug, Other, Radiation, Other
ARM I (high-dose cisplatin, radiation therapy)Experimental Group · 4 Interventions: Cisplatin, Quality-of-Life Assessment, Radiation Therapy, Questionnaire Administration · Intervention Types: Drug, Other, Radiation, Other
Arm II (low-dose cisplatin, radiation therapy)Experimental Group · 4 Interventions: Cisplatin, Quality-of-Life Assessment, Radiation Therapy, Questionnaire Administration · Intervention Types: Drug, Other, Radiation, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7360

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 years

Who is running the clinical trial?

NRG OncologyLead Sponsor
221 Previous Clinical Trials
94,696 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,264 Total Patients Enrolled
Paul M HarariPrincipal InvestigatorNRG Oncology
1 Previous Clinical Trials
613 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate in the trial if you have had or currently have another type of cancer that will not affect the safety or effectiveness of the investigational treatment.
If you smoke cigars or pipes, that won't be counted towards the total number of years you've smoked. Likewise, smoking marijuana won't be included in the calculation. There is no clear evidence about the link between chewing tobacco and oropharyngeal cancer, but it's still a concern due to the proximity of the oral cavity and oropharynx. However, non-cigarette tobacco products won't be counted in the calculation of pack-years.

Who else is applying?

What state do they live in?
Louisiana100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Louisiana State University Health Science Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

How many patients are being treated with this new medication?

"464 volunteers that meet the pre-determined eligibility requirements are necessary to enroll in this study. The trial is being conducted at Parkland Health Center - Farmington in Farmington, Missouri and IHA Hematology Oncology Consultants-Ann Arbor in Ypsilanti, Michigan." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial being run in multiple locations throughout Canada?

"One hundred different medical facilities are participating in this clinical trial, with locations in Farmington, Ypsilanti, Cape Girardeau, and many other cities. If you enroll, try to pick a centre near you to limit travel." - Anonymous Online Contributor

Unverified Answer

Are people with the required medical conditions still being accepted into this trial period?

"The information on clinicaltrials.gov indicates that this trial is currently recruiting participants. The trial was originally posted on October 27, 2021 and was last updated on August 12, 2022." - Anonymous Online Contributor

Unverified Answer

What is the main purpose of Quality-of-Life Assessment?

"Quality-of-Life Assessment is a standard neoplasm metastasis treatment, but can also be useful in managing advanced ovarian cancer, refractory conditions, and advance directives." - Anonymous Online Contributor

Unverified Answer

Is this the first research project to focus on Quality-of-Life Assessment?

"The first Quality-of-Life Assessment study was completed in 1997 at City of Hope Comprehensive Cancer Center. There have been a total of 1277 such studies completed to date. There are presently 773 clinical trials actively recruiting, a majority of which are based in Farmington, Missouri." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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