Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
65

Inclusion Criteria

Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
Karnofsky performance status >= 70%
...
Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
Karnofsky performance status >= 70%
Participants must have the ability to understand and the willingness to sign a written consent form

Exclusion Criteria

Female participants who are pregnant or breast feeding
Participants who had prior head and neck radiation therapy
Participants who have received induction chemotherapy before radiation treatment
...
Female participants who are pregnant or breast feeding
Participants who had prior head and neck radiation therapy
Participants who have received induction chemotherapy before radiation treatment
Participants who are not able to comply with study and/or follow up procedures
Participants who are enrolled in a national/international cooperative group trials
Patients with metastatic disease

Summary

Conditions
  • Head and Neck Cancer
  • Hypopharynx Cancer
  • Larynx Cancer
  • Nasopharynx Cancer
  • Oral Cavity Cancer
  • Oropharynx Cancer
  • Paranasal Sinus Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
Karnofsky performance status >= 70%
...
Participants with pathologically confirmed cancers of paranasal sinuses, oropharynx, oral cavity, nasopharynx, larynx, hypopharynx, and unknown primary and will receive definitive radiation therapy with or without chemotherapy.
Women of childbearing potential need to have a negative serum pregnancy test at the time of therapy
Karnofsky performance status >= 70%
Participants must have the ability to understand and the willingness to sign a written consent form

Exclusion Criteria

Female participants who are pregnant or breast feeding
Participants who had prior head and neck radiation therapy
Participants who have received induction chemotherapy before radiation treatment
...
Female participants who are pregnant or breast feeding
Participants who had prior head and neck radiation therapy
Participants who have received induction chemotherapy before radiation treatment
Participants who are not able to comply with study and/or follow up procedures
Participants who are enrolled in a national/international cooperative group trials
Patients with metastatic disease

Locations

Middletown, New Jersey, 07748
New York, New York, 10065
Basking Ridge, New Jersey, 07920
Montvale, New Jersey, 07645
Commack, New York, 11725
...
Middletown, New Jersey, 07748
New York, New York, 10065
Basking Ridge, New Jersey, 07920
Montvale, New Jersey, 07645
Commack, New York, 11725
Rockville Centre, New York, 11570
Uniondale, New York, 11553
Harrison, New York, 10604

Tracking Information

NCT #
NCT03096808
Collaborators
Not Provided
Investigators
  • Principal Investigator: C. Jillian Tsai, MD Memorial Sloan Kettering Cancer Center
  • C. Jillian Tsai, MD Memorial Sloan Kettering Cancer Center