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Alkylating agents

Stereotactic Body Radiation Therapy (SBRT) for Squamous Cell Carcinoma

Phase 1

Waitlist Available

Led By Jimmy Caudell, M.D., Ph.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing different doses of radiation to see which is most effective in controlling the growth of head/neck cancer along with the chemotherapy drug cisplatin.

Eligible Conditions

Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal Tolerated Dose (MTD) of Stereoactive Body Radiation Therapy (SBRT)

Secondary outcome measures

Local Control Rate

Overall Survival (OS)

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation: SBRT and CisplatinExperimental Treatment2 Interventions

Stereotactic Body Radiation Therapy (SBRT) and Cisplatin. Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy/ Cisplatin 15 mg/m^2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,472 Total Patients Enrolled

Jimmy Caudell, M.D., Ph.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of the cohort being observed in this research experiment?

"This investigation is not presently enrolling, having been initially posted on July 16th 2014 and last updated on August 18th 2022. However, there are currently 2675 studies seeking participants with oral squamous cell carcinoma and 689 trials in search of volunteers for Stereotactic Body Radiation Therapy (SBRT)."

Answered by AI

What maladies has SBRT been utilized to address?

"SBRT is traditionally used to treat advanced ovarian cancer. However, this therapy can also be employed for conditions such as refractory testicular cancer and other forms of malignancy with advanced directives."

Answered by AI

Are there still vacancies available for participation in this research project?

"Clinicaltrials.gov states that enrollment for this trial has been closed since August 18th, 2022. First posted on July 16th 2014, the study is no longer accepting volunteers; however there are 3364 other medical trials searching for participants at present."

Answered by AI

What adverse effects could result from Stereotactic Body Radiation Therapy (SBRT) for patients?

"Our team at Power assigned SBRT a safety score of 1, since this is only in the initial Phase 1 trial with limited evidence for its efficacy and security."

Answered by AI

How has Stereotactic Body Radiation Therapy (SBRT) been evaluated in other research projects?

"Currently, there are 689 medical studies researching the efficacy of Stereotactic Body Radiation Therapy (SBRT), with 274 trials already in Phase 3. Notably, Shanghai alone boasts 43222 SBRT clinical trial sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck

2014. "Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02158234.