~31 spots leftby Apr 2026

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Head and Neck Cancer

Recruiting in Palo Alto (17 mi)
+194 other locations
PF
Overseen byPhuc Felix Nguyen-Tan, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Radiation Therapy Oncology Group
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer. PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.

Research Team

PF

Phuc Felix Nguyen-Tan, MD

Principal Investigator

CHUM Hospital Notre Dame

Eligibility Criteria

Inclusion Criteria

Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
No metastases below the clavicle or more distant by clinical exam or radiology
See 6 more

Treatment Details

Interventions

  • Accelerated fractionation radiation therapy (Radiation)
  • Cisplatin (Alkylating agents)
  • Conventional surgery for select patients (Surgery)
  • Standard fractionation RT (Radiation)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard fractionation RT + cisplatinExperimental Treatment3 Interventions
Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
Group II: Accelerated fractionation RT + cisplatinExperimental Treatment3 Interventions
Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials
191
Recruited
64,900+
Dr. Vivek S. Kavadi profile image

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

Dr. Gita Suneja profile image

Dr. Gita Suneja

Radiation Therapy Oncology Group

Chief Medical Officer

MD from University of Utah School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials
242
Recruited
105,000+
Stephanie Gaillard profile image

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School