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Cisplatin for Head and Neck Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic Hospital in Arizona, Phoenix, AZHead and Neck Cancer+10 MoreCisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether proton therapy can shrink tumors in patients with head and neck cancer.

Eligible Conditions
  • Head and Neck Cancer
  • Head and Neck Cancer of Unknown Primary
  • Hypopharyngeal Cancer
  • Laryngeal Cancer
  • Metastatic Lymph Node Cancer
  • Nasal Cavity Cancer
  • Oral Cancer
  • Paranasal Sinus Cancer
  • Salivary Gland Cancer
  • Skin Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Patient Observation
1
Radiation Therapy
1
Radiation Therapy

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Up to 10 years

At 2 years
Rate of local/regional control (LRF)
Year 10
Overall survival (OS)
Year 10
Invasive disease-free survival (DFS)
Up to 10 years
Distant recurrence rates
Local recurrence incidence
Quality of life (QOL) and financial burden
Regional recurrence rates
Month 3
Incidence of secondary acute effects attributable to radiation therapy
Month 3
Incidence of acute adverse events
Year 3
Incidence of late adverse events

Trial Safety

Safety Progress

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

Similar Trials

1
Patient Observation
1
Radiation Therapy
2
Radiation Therapy

Trial Design

2 Treatment Groups

Arm A (IMPT, cisplatin)
1 of 2
Arm B (IMPT, cisplatin)
1 of 2

Experimental Treatment

117 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2

Arm A (IMPT, cisplatin)Experimental Group · 4 Interventions: Cisplatin, Intensity-Modulated Proton Therapy, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Procedure, Other, Other
Arm B (IMPT, cisplatin)Experimental Group · 4 Interventions: Cisplatin, Intensity-Modulated Proton Therapy, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Drug, Procedure, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chloride ion
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,156 Previous Clinical Trials
41,163,489 Total Patients Enrolled
274 Trials studying Head and Neck Cancer
34,841 Patients Enrolled for Head and Neck Cancer
Mayo ClinicLead Sponsor
2,958 Previous Clinical Trials
3,449,316 Total Patients Enrolled
10 Trials studying Head and Neck Cancer
837 Patients Enrolled for Head and Neck Cancer
Scott C LesterPrincipal InvestigatorMayo Clinic in Rochester

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have cancer in the head and neck area, including the nose, mouth, throat, and glands, or skin cancer that has spread to the lymph nodes and requires radiation therapy.
References

Frequently Asked Questions

Are we currently enrolling people for this research project?

"Yes, this information can be found on clinicaltrials.gov. The trial was first advertised on February 21st 2021 and the most recent update was April 6th 2022." - Anonymous Online Contributor

Unverified Answer

Are there other examples in the medical literature of Cisplatin being used in treatment?

"City of Hope Comprehensive Cancer Center first studied cisplatin in 1997 and, as of now, 1198 trials have been completed while 773 are ongoing. A considerable number of these active studies are based in Rochester, Minnesota." - Anonymous Online Contributor

Unverified Answer

What is the primary purpose that Cisplatin is prescribed?

"Cisplatin is used to treat neoplasm metastasis and other conditions like advanced ovarian cancer. It may be employed when standard therapies have failed or in advance directives." - Anonymous Online Contributor

Unverified Answer

What is the projected sample size for this experiment?

"Yes, this study is open for recruitment and the clinicaltrials.gov website has the most recent information. The trial was first posted on February 21st, 2021 and was edited April 6th, 2022. There are plans to enroll 117 patients at 2 sites." - Anonymous Online Contributor

Unverified Answer

Does the FDA sanction use of Cisplatin?

"Cisplatin received a score of 2 from our team because while there is some data suggesting it is safe, none of the available information points to this medication being effective." - 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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