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

Conditions

Early-Stage Squamous Cell Carcinoma of the Oropharynx

Brief summary

The historical standard treatment for early-stage squamous cell carcinoma of the oropharynx is radiation therapy. Some patients require chemotherapy with the radiation, and some patients require surgery if the tumour or lymph nodes have not responded after radiation. This study will compare radiation therapy with a new surgical treatment called transoral robotic surgery (TORS). TORS is a new surgical approach using a robot to assist the surgeon in removing the tumour, potentially with fewer side effects than older surgical techniques.

Anthony C. Nichols, Julie Theurer, Eitan Prisman, Nancy Read, Eric Berthelet et al. (32 authors)

Journal of Clinical Oncology2022-01-07156 citations

10.1200/jco.21.01961

Radiotherapy versus transoral robotic surgery and neck dissection for oropharyngeal squamous cell carcinoma (ORATOR): an open-label, phase 2, randomised trial.

Nichols AC, Theurer J, Prisman E, Read N, Berthelet E, Tran E, Fung K, de Almeida JR, Bayley A, Goldstein DP, Hier M, Sultanem K, Richardson K, Mlynarek A, Krishnan S, Le H, Yoo J, MacNeil SD, Winquist E, Hammond JA, Venkatesan V, Kuruvilla S, Warner A, Mitchell S, Chen J, Corsten M, Johnson-Obaseki S, Eapen L, Odell M, Parker C, Wehrli B, Kwan K, Palma DA.

2019-08-12305 citations

10.1016/s1470-2045(19)30410-3

A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy versus trans-oral robotic surgery (ORATOR).

Anthony C. Nichols, Julie Theurer, Eitan Prisman, Nancy Read, Eric Berthelet et al. (20 authors)

Journal of Clinical Oncology2019-05-208 citations

10.1200/jco.2019.37.15_suppl.6006

Early-stage squamous cell carcinoma of the oropharynx: radiotherapy vs. trans-oral robotic surgery (ORATOR)--study protocol for a randomized phase II trial.

Nichols AC, Yoo J, Hammond JA, Fung K, Winquist E, Read N, Venkatesan V, MacNeil SD, Ernst DS, Kuruvilla S, Chen J, Corsten M, Odell M, Eapen L, Theurer J, Doyle PC, Wehrli B, Kwan K, Palma DA.

2013-03-20107 citations

10.1186/1471-2407-13-133

Interventions

RADIATIONRadiotherapy

Gross Tumour and Nodes: 70 Gy in 35 fractions over 7 weeks. High-risk nodal areas: 63 Gy in 35 fractions over 7 weeks. Low-risk nodal areas: 56 Gy in 35 fractions over 7 weeks

PROCEDURETransoral Robotic Surgery + Neck Dissection

Transoral robotic excision will be carried out using the da Vinci surgical robot.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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, or N2 (less than or equal to 4 cm in maximum dimension in any plane, 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

Design outcomes

Primary

Measure	Time frame
Quality of Life	1-year post treatment

Secondary

Measure	Time frame
Overall Survival	At the end of 3 years and at the end of 5 years
Progression-free survival	At the end of 3 years and at the end of 5 years
Quality of life at other time points	Every 6 months for 5 years from 1st date of treament
Toxicity	5 years from date of first treatment
Swallowing Function	5 years from date of first treatment

Countries

Australia, Canada

Outcome results

None listed