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RTOG 1216

Status:

Suspended | Phase II/III 

Official Title:

Randomized phase II/III trial of surgery and postoperative radiation delivered with concurrent cisplatin versus docetaxel versus docetaxel and cetuximab for high-risk squamous cell cancer of the head and neck

Study Purpose:

To find out what effects, good and/or bad, treatment has on you and your cancer.  

Interventions:

  • ARM I:  Radiation therapy for 6 weeks and cisplatin for 6 doses.
  • ARM II:  Radiation therapy for 6 weeks and docetaxel for 6 doses.
  • ARM III:  Radiation therapy for 6 weeks and docetaxel for 6 doses and cetuximab.

Patients will be followed every 3 months for 2 years, every 6 months for 3 years, then annually.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Pathologic stage III or IV head and neck squamous cell carcinoma involving the oral cavity (excluding lips), oropharynx (p16 negative), larynx, or hypopharynx.

Eligibility:

Prior chemotherapy for a different cancer is allowable.

No prior systemic chemotherapy or anti-EGF for this cancer.

No prior radiation to the region of this cancer that would result in overlap of radiation therapy fields.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

RTOG 1216

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!