Phase III randomized clinical trial of elective neck irradiation in oropharyngeal squamous cell cancer: Is high dose necessary?

In era of HPV related oropharyngeal cancer which contribute the better prognosis of treatment outcomes. This study will evaluate whether conventional high dose (56 Gy in 1.6 Gy/F) and experimental low dose ( 50 Gy in 1.43 Gy/F ) radiation to the elec

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20180203001

Enrollment

180

Registered

2018-02-03

Start date

2015-08-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal squamous cell cancer

Interventions

Dose 56 Gy in 1.6 Gy/F to elective neck area, Dose 56 Gy in 1.6 Gy/F to elective neck area

No Intervention Radiation,Experimental Radiation

conventional high dose (56 Gy in 1.6 Gy/F),experimental low dose ( 50 Gy in 1.43 Gy/F )

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Stage I-IVB oropharyngeal cancer -Adequate performance status -Anticipated to the informed consent

Exclusion criteria

Exclusion criteria: -Evidence of distant metastasis -Recurrent oropharyngeal cancer -Undergone surgery upon primary tumor or neck apart from incisional or excisional biopsy -Previous irradiation for head neck tumor -Prior chemotherapy to study entry -History of malignancy other than non-melanoma skin cancer which is controlled at least 5 years

Design outcomes

Primary

Measure	Time frame
Locoregional control 2 years Rate of recurrence in elective neck area	—

Secondary

Measure	Time frame
Acute toxicities During radiation treatment CTCAE 4.03,Late toxicities 2 years CTCAE 4.03	—

Contacts

Public ContactDanita Kannarunimit

Division of Radiation Oncology,Faculty of Medicine, Chulalongkorn University

danita.k@chula.ac.th222564334

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026