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A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Early-Stage Squamous Cell Carcinoma of the Oropharynx

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Trial Information

A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR)


Inclusion Criteria:



- age 18 or older

- willing to provide informed consent

- ECOG performance status 0-2

- Histologically confirmed squamous cell carcinoma primary rumour site in the
oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)

- Tumour stage:T1 or T2, with likely negative resections at surgery

- Nodal stage: N0, N1 (<=3cm), or N2 (up to 2 nodes between 1-3cm, on either side of
the neck), without extranodal extension on pre-randomization imaging.

- Patient assessed at head and neck multidisciplinary clinic (with assessment by
radiation oncologist and surgeon) and presented at multidisciplinary tumour board
prior to randomization.

Exclusion Criteria:

- Serious medical comorbidities or other contraindications to radiotherapy,
chemotherapy or surgery

- Prior history of head and neck cancer within 5 years

- Prior head and neck radiation at any time

- Metastatic disease

- Inability to attend full course of radiotherapy or follow-up visits

- Neck disease with unknown primary site

- Prior invasive malignant disease unless disease-free for at least 5 years or more,
with the exception of non-melanoma skin cancer

- unable or unwilling to complete QoL questionnaires

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality of Life

Outcome Time Frame:

1-year post treatment

Safety Issue:

No

Principal Investigator

David Palma, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Regional Cancer Program of the Lawson Health Research Institute

Authority:

Canada: Ethics Review Committee

Study ID:

ORATOR

NCT ID:

NCT01590355

Start Date:

June 2012

Completion Date:

June 2021

Related Keywords:

  • Early-Stage Squamous Cell Carcinoma of the Oropharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Oropharyngeal Neoplasms

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