Radiation Therapy in Treating Patients With Stage II Cancer of the Vocal Cord

Recruiting at236 trial locations

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

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in treating patients with stage II cancer of the vocal cord. PURPOSE: Randomized phase III trial to compare two regimens of radiation therapy in treating patients who have stage II cancer of the vocal cord.

Research Team

Andy M. Trotti, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

Inclusion Criteria

Histologically proven invasive squamous cell carcinoma of the true vocal cord

Stage II (T2a/b N0) disease with bulk of tumor present on vocal cord (i.e., the epicenter) with extension to adjacent areas

No verrucal carcinoma or adenocarcinoma

Treatment Details

Interventions

• Radiation Therapy (Radiation)

Participant Groups

Group I: Radiation therapy - hyperfractionation Experimental Treatment 1 Intervention

Radiation therapy - hyperfractionation (79.2 Gy/1.2 b.i.d/6.5 weeks) 66 fractions

Group II: Radiation therapy - conventional fractionation Active Control 1 Intervention

Radiation therapy - conventional fractionation (70 Gy/2 Gy once per day/7 Weeks) 35 fractions

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

Dr. Vivek S. Kavadi

Radiation Therapy Oncology Group

Chief Executive Officer

MD from Harvard Medical School, MBA from The Wharton School

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

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School