A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR) (ORATOR)
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| ClinicalTrials.gov Identifier: NCT01590355 |
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Recruitment Status :
Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : September 2, 2019
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Sponsor:
Lawson Health Research Institute
Information provided by (Responsible Party):
David Palma, Lawson Health Research Institute
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Early-Stage Squamous Cell Carcinoma of the Oropharynx | Radiation: Radiotherapy Procedure: Transoral Robotic Surgery + Neck Dissection | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 68 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II Randomized Trial for Early-stage Squamous Cell Carcinoma of the Oropharynx: Radiotherapy vs Trans-oral Robotic Surgery (ORATOR) |
| Study Start Date : | June 2012 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Radiotherapy plus or minus Chemotherapy
Radiotherapy plus or minus chemotherapy with surgical treatment for salvage of persistent disease
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Radiation: Radiotherapy
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 |
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Experimental: Transoral Robotic Surgery + Neck Dissection
Transoral robotic excision will be carried out using the da Vinci surgical robot. The spatula cautery will be used to remove the tumours with 1 cm margins. At the time of surgery circumferential margins will be taken and sent for frozen section analysis. The resection will proceed until negative margins are obtained if feasible.
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Procedure: Transoral Robotic Surgery + Neck Dissection
Transoral robotic excision will be carried out using the da Vinci surgical robot. |
Primary Outcome Measures :
- Quality of Life [ Time Frame: 1-year post treatment ]
Secondary Outcome Measures :
- Overall Survival [ Time Frame: At the end of 3 years and at the end of 5 years ]
- Progression-free survival [ Time Frame: At the end of 3 years and at the end of 5 years ]
- Quality of life at other time points [ Time Frame: Every 6 months for 5 years from 1st date of treament ]
- Toxicity [ Time Frame: 5 years from date of first treatment ]
- Swallowing Function [ Time Frame: 5 years from date of first treatment ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590355
Locations
| Australia | |
| Royal Adelaide Hospital | |
| Adelaide, Australia, 5000 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency | |
| Vancouver, British Columbia, Canada, V5Z4E6 | |
| Canada, Ontario | |
| London Regional Cancer Program of the Lawson Health Research Institute | |
| London, Ontario, Canada, N6A 4L6 | |
| The Ottawa Hospital Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G2M9 | |
| Canada, Quebec | |
| Jewish General Hospital | |
| Montréal, Quebec, Canada, H3T 1E2 | |
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
| Principal Investigator: | David Palma, MD, PhD | London Regional Cancer Program of the Lawson Health Research Institute | |
| Principal Investigator: | Anthony Nichols, MD | London Regional Cancer Program of the Lawson Health Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Palma, Principal Investigator, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01590355 History of Changes |
| Other Study ID Numbers: |
ORATOR |
| First Posted: | May 2, 2012 Key Record Dates |
| Last Update Posted: | September 2, 2019 |
| Last Verified: | August 2019 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |