Stereotactic Radiotherapy + Cisplatin for Head and Neck Cancer

Overseen by Jonathan D. Schoenfeld, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research study seeks to gain new knowledge about the addition of a carefully targeted "boost" dose of radiation as a possible treatment for recurrent or metastatic head or neck cancer. The name of the study intervention involved in this study is stereotactic body radiotherapy, which is a way of delivering radiation in a more precisely targeted way and with a higher dose than conventional radiotherapy.

Research Team

Jonathan D. Schoenfeld, MD MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Adults with recurrent or metastatic head and neck cancer, who have measurable disease in the region, can join this trial. They must not have other active cancers (except certain skin cancers or cervical carcinoma in situ), be medically fit for treatment, and have normal organ/marrow function. Pregnant women, individuals with large SBRT target sizes (>6 cm or >100 cc), those on specific medications like Bevacizumab or anti-tumor necrosis factor agents, and HIV-positive patients on antiretroviral therapy are excluded.

Inclusion Criteria

I haven't had any cancer except for skin cancer or cervical pre-cancer in the last 2 years.

I have a solid tumor in my head or neck that has spread and can be measured.

My cancer has been confirmed through lab tests.

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

My treatment target is larger than 6 cm or more than 100 cc in volume.

I am scheduled to receive treatments like G-CSF or Bevacizumab.

Treatment Details

Interventions

• Cisplatin (Alkylating agents)
• Intensity Modulated Radiation Therapy (IMRT) (Radiation)
• Stereotactic Body Radiotherapy (SBRT) (Proton Beam Therapy)

Trial Overview The study is testing whether adding a high-dose precision radiation 'boost' using Stereotactic Body Radiotherapy (SBRT) to standard treatments like Cisplatin chemotherapy and Intensity Modulated Radiation Therapy (IMRT) improves outcomes for patients with head and neck cancer that has returned or spread.

Participant Groups

Group I: Cohort 2 Experimental Treatment 1 Intervention

* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 2 (patients with metastatic solid tumors of any histology who have targetable lesions within the head and neck) -- Stereotactic Body Radiotherapy (SBRT)

Group II: Cohort 1 Experimental Treatment 3 Interventions

* Dose escalation will occur using a standard 3+3 dose escalation approach, beginning in dose level I with dose cohorts and rules for escalation and de-escalation. * Cohort 1 (patients who have received prior radiation in the head and neck with gross unresectable disease) * Intensity Modulated Radiation Therapy (IMRT) : daily for 6 weeks * Cisplatin will be administered intravenously on predetermined days * Stereotactic Body Radiotherapy (SBRT)

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management