Oropharynx CancerPhase 2NECTORSNCT04277858
Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
A Phase 2 study testing Docetaxel in people with Oropharynx Cancer and Tonsil Cancer, run by Nader Sadeghi at 1 site in Canada.
Trial summary
The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Oropharynx Cancer, Tonsil Cancer, Throat Cancer
- What is being tested?
- Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 14 Aug 2018to 30 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous cell cancer of oropharynx, p 16 positive
- American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2)
- Treatment Naive
- No evidence of distant metastatic disease
- Fit for surgery, and primary tumor assessed surgically resectable with negative margins via transoral approach
- Age > 18 years
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- Karnofsky performance status > 60% or Eastern Cooperative Oncology Group (ECOG) < 2
- Absolute neutrophil count (ANC) > 2,000, platelets > 100,000 and calculated creatinine clearance > 50 cc/min
- Signed study specific consent form
- No other malignancies except cutaneous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the last 5 years
- Agree to use effective contraception while on the study. Women of child bearing potential must have a negative pregnancy test, and not be lactating.
Who cannot join
- Patients with advanced T4 cancer unresectable without organ preservation
- P16 negative tumor
- N3 disease (Stage IVB AJCC-7)
- 5 or more positive cervical lymph nodes at presentation
- Distant metastatic disease (Stage IVC)
- Radiological evidence of gross extracapsular nodal tumor invasion
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- Anatomy not allowing transoral access and exposure
- Prior head and neck cancer at any time (Other than BCC or SCC of skin)
- Coexistent second malignancy or history within 5 years of prior malignancy (other than BCC or early SCC skin or curatively treated Stage I carcinoma of cervix)
- Peripheral neuropathy >/= grade 1
- Have had prior Taxanes or Cisplatin
- Concurrent infection
- Coexisting medical illness of a severity that might interfere with treatment or follow-up, or who do not have the ability to give informed consent.
- Receiving any other investigational agent while on the study
Trial locations and contacts
1 site in 1 country.
Elizabeth Beaubien contact
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Nader Sadeghi, 5149341934 ext. 34974, nader.sadeghi@mcgill.ca
Elizabeth Beaaubien, 514-934-1934 ext. 34974, elizabeth.beaubien@muhc.mcgill.ca
About this study
Official title: Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial)
The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.
Read the detailed description
The current standard of care for advanced (AJCC-7 edition stage III and IV) oropharyngeal squamous cell carcinoma are concomitant chemoradiation, or surgery followed by adjuvant radiation therapy with or without concomitant chemotherapy. These approaches have persistent and significant lifelong side effects and sequelae related to treatment, and in particular related to radiotherapy. The side effects of radiotherapy (augmented with concomitant chemotherapy) include soft tissue fibrosis, loss of salivary function, dry mouth, life long disturbed taste function, poor dental health with rapidly decaying teeth, dysfunction of swallowing, significant loss of the mobility of the base of tongue and pharyngeal constrictors, loss of laryngeal elevation, esophageal stricture, and at times severe side effects such as soft tissue necrosis or osteoradionecrosis of the mandible. About 10% of the patients undergoing chemoradiation for oropharyngeal cancer develop long term swallowing dysfunction with feeding tube dependency. As a result , patient's quality of life (QOL) is adversely affected. Improvements in the side effect profile of treatment, the functional outcome, and the QOL remain very important areas of advancement in treating this patient population. Improvements in functional outcome need to be achieved while maintaining or improving the oncologic outcome and cure rates for cancer, compared to the standard of care.
Use of Taxane based chemotherapy along with Platinum drugs (Cisplatin and Carboplatin) in high dose neoadjuvant setting, coupled with Transoral Laser Microsurgery (TLM) or Transoral Robotic Assisted Surgery (TORS), allows potential for improved oncologic outcome as well as avoidance of long term sequelae of high dose radiation therapy to head and neck. These transoral surgical approaches (TLM and TORS) provide improved functional outcome compared with traditional open composite resections and complex reconstructive algorithms for oropharynx. TLM and TORS are currently in clinical use for early (stage T1 and T2 with N0 or N+ve) oropharyngeal cancer.
De-escalation treatment strategies of TORS followed by adjuvant radiotherapy are being investigated currently. However even without de-escalation there is overall 18-20% rate of treatment failure and half of failures are due to distant metastasis in the absence of loco-regional recurrence. In this study the investigators propose systemic escalation of treatment with neoadjuvant chemotherapy (docetaxel and cisplatin) followed by de-escalated locoregional treatment with transoral surgery and neck dissection reserving radiotherapy for salvage.
This approach has the potential for improved functional outcome by avoiding short and more importantly long term and permanent sequelae of radiation therapy in oropharyngeal cancer treatment. This approach is a new paradigm in treatment of oropharyngeal cancer, and can significantly improve the functional outcome of cancer treatment.
- Being tested
- Docetaxel
- Keywords
- oropharynx cancer, throat cancer, HPV related throat cancer, tonsil cancer, base of tongue cancer
- Medical subject headings
- Oropharyngeal Neoplasms, Tonsillar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Cisplatin, Transoral robotic surgery
Subjects will be treated with neoadjuvant docetaxel and cisplatin for 3 cycles. This is followed by transoral robotic surgery (TORS) and neck dissection as definitive treatment, reserving radiotherapy for salvage.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy and surgery | Experimental | Docetaxel and Cisplatin x 3 cycles followed by Transoral robotic surgery and neck dissection.
Carboplatin may be used instead of Cisplatin. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome: progression free survival.
Subjects will be evaluated for cancer recurrence or persistence. Index cancer recurrence or persistence following completion of treatment at any site will be recorded as an event. Progression free survival will be calculated at 2 years according to the Kaplan Meier methods.
Measured: 2 years
Secondary outcomes (4)
Disease Specific Survival (DSS)
The trial subjects will be followed for vital statistics (dead or alive) from the time enrolled in the trial. Any deaths that is caused by the index cancer will count as an event. DSS will be calculated with intention to treat analysis according to the Kaplan Meier methods at 5 years.
Measured: 5 years
Overall Survival (OS)
The trial subjects will be followed for vital statistics (dead or alive) from the time of enrolment. Death from any cause will be counted as an event. Overall survival will be calculated according to the Kaplan Meier methods at years.
Measured: 5 years
General Quality of Life (QOL)
Patient-reported general quality of life outcome will be measured according to The European Organization for Research and Treatment of Cancer (EORTC) general quality of life questionnaire (EORTC QLQ-C30) at 3 month, 6 months, and 12 months following the completion of treatment. These questionnaires are validated and an integrated system for assessing the quality of life (QoL) of cancer patients participating in clinical trials. Outcome score for functional scales at 12 months will be compared to pretreatment levels.
Measured: 12 months.
Head and Neck Specific Quality of Life (QOL)
Patient-reported quality of life outcome will be measured according to EORTC head and neck specific questionnaire (QLQ-H\&N35) prior to trial treatment (baseline), at 3 month, 6 months, and 12 months following the completion of treatment. These questionnaires are validated and an integrated system for assessing the quality of life (QoL) of head and neck cancer patients participating in clinical trials. Outcomes for symptom scales in H\&N-35 at 12 months will be compared to pretreatment levels.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start14 Aug 2018
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- neoadjuvant Docetaxel and Cisplatin and transoral surgery
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nader Sadeghi
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Sponsor-investigator, Nader Sadeghi, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Nader Sadeghi, MD, Study chair, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277858
- Sponsor's protocol ID
- MP-37-2018-3443
- Acronym
- NECTORS
- Status last verified
- Oct 2023
- First submitted
- 11 Dec 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sadeghi N, Mascarella MA, Khalife S, Ramanakumar AV, Richardson K, Joshi AS, Taheri R, Fuson A, Bouganim N, Siegel R. Neoadjuvant chemotherapy followed by surgery for HPV-associated locoregionally advanced oropharynx cancer. Head Neck. 2020 Aug;42(8):2145-2154. doi: 10.1002/hed.26147. Epub 2020 Mar 25.
PubMed 32212296Sadeghi N, Khalife S, Mascarella MA, Ramanakumar AV, Richardson K, Joshi AS, Bouganim N, Taheri R, Fuson A, Siegel R. Pathologic response to neoadjuvant chemotherapy in HPV-associated oropharynx cancer. Head Neck. 2020 Mar;42(3):417-425. doi: 10.1002/hed.26022. Epub 2019 Nov 27.
PubMed 31773857Sadeghi N, Li NW, Taheri MR, Easley S, Siegel RS. Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach. Head Neck. 2016 Dec;38(12):1837-1846. doi: 10.1002/hed.24526. Epub 2016 Jun 14.
PubMed 27299983Sadeghi N, Subramaniam T, Richardson K, Mascarella M, Zeitouni A, Shenouda G, Sultanem K, Mlynarek A, Caglar D, Esfahani K, Joshi A, Siegel R, Goodman J, Thakkar P, Lee E, Golabi N, Ramanakumar AV, Hier M, Bouganim N. Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Human Papillomavirus-Related Oropharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2025 Feb 1;151(2):128-134. doi: 10.1001/jamaoto.2024.3303.
PubMed 39636629
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study: Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Definitive Management of Oropharyngeal Squamous Cell Carcinoma. (NECTORS Trial)
- ClinicalTrials.gov ID
- NCT04277858
- Acronym / sponsor ID
- NECTORS / MP-37-2018-3443
- Keywords
- oropharynx cancer, throat cancer, HPV related throat cancer, tonsil cancer, base of tongue cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nader SadeghiUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.
Detailed description
The current standard of care for advanced (AJCC-7 edition stage III and IV) oropharyngeal squamous cell carcinoma are concomitant chemoradiation, or surgery followed by adjuvant radiation therapy with or without concomitant chemotherapy. These approaches have persistent and significant lifelong side effects and sequelae related to treatment, and in particular related to radiotherapy. The side effects of radiotherapy (augmented with concomitant chemotherapy) include soft tissue fibrosis, loss of salivary function, dry mouth, life long disturbed taste function, poor dental health with rapidly decaying teeth, dysfunction of swallowing, significant loss of the mobility of the base of tongue and pharyngeal constrictors, loss of laryngeal elevation, esophageal stricture, and at times severe side effects such as soft tissue necrosis or osteoradionecrosis of the mandible. About 10% of the patients undergoing chemoradiation for oropharyngeal cancer develop long term swallowing dysfunction with feeding tube dependency. As a result , patient's quality of life (QOL) is adversely affected. Improvements in the side effect profile of treatment, the functional outcome, and the QOL remain very important areas of advancement in treating this patient population. Improvements in functional outcome need to be achieved while maintaining or improving the oncologic outcome and cure rates for cancer, compared to the standard of care.
Use of Taxane based chemotherapy along with Platinum drugs (Cisplatin and Carboplatin) in high dose neoadjuvant setting, coupled with Transoral Laser Microsurgery (TLM) or Transoral Robotic Assisted Surgery (TORS), allows potential for improved oncologic outcome as well as avoidance of long term sequelae of high dose radiation therapy to head and neck. These transoral surgical approaches (TLM and TORS) provide improved functional outcome compared with traditional open composite resections and complex reconstructive algorithms for oropharynx. TLM and TORS are currently in clinical use for early (stage T1 and T2 with N0 or N+ve) oropharyngeal cancer.
De-escalation treatment strategies of TORS followed by adjuvant radiotherapy are being investigated currently. However even without de-escalation there is overall 18-20% rate of treatment failure and half of failures are due to distant metastasis in the absence of loco-regional recurrence. In this study the investigators propose systemic escalation of treatment with neoadjuvant chemotherapy (docetaxel and cisplatin) followed by de-escalated locoregional treatment with transoral surgery and neck dissection reserving radiotherapy for salvage.
This approach has the potential for improved functional outcome by avoiding short and more importantly long term and permanent sequelae of radiation therapy in oropharyngeal cancer treatment. This approach is a new paradigm in treatment of oropharyngeal cancer, and can significantly improve the functional outcome of cancer treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- neoadjuvant Docetaxel and Cisplatin and transoral surgery
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy and surgery | Experimental | Drug: DocetaxelDocetaxel and Cisplatin x 3 cycles followed by Transoral robotic surgery and neck dissection. Carboplatin may be used instead of Cisplatin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Squamous cell cancer of oropharynx, p 16 positive
- American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2)
- Treatment Naive
- No evidence of distant metastatic disease
- Fit for surgery, and primary tumor assessed surgically resectable with negative margins via transoral approach
Key exclusion criteria (14 listed)
- Patients with advanced T4 cancer unresectable without organ preservation
- P16 negative tumor
- N3 disease (Stage IVB AJCC-7)
- 5 or more positive cervical lymph nodes at presentation
- Distant metastatic disease (Stage IVC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Cisplatin, Transoral robotic surgerySubjects will be treated with neoadjuvant docetaxel and cisplatin for 3 cycles. This is followed by transoral robotic surgery (TORS) and neck dissection as definitive treatment, reserving radiotherapy for salvage. | Drug | Neoadjuvant chemotherapy and surgery |
Primary outcome
Primary outcome: progression free survival.
Time frame: 2 years
Subjects will be evaluated for cancer recurrence or persistence. Index cancer recurrence or persistence following completion of treatment at any site will be recorded as an event. Progression free survival will be calculated at 2 years according to the Kaplan Meier methods.
4 secondary outcomes
Disease Specific Survival (DSS)
Time frame: 5 years
Overall Survival (OS)
Time frame: 5 years
General Quality of Life (QOL)
Time frame: 12 months.
Head and Neck Specific Quality of Life (QOL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 32212296Sadeghi N, Mascarella MA, Khalife S, Ramanakumar AV, Richardson K, Joshi AS, Taheri R, Fuson A, Bouganim N, Siegel R. Neoadjuvant chemotherapy followed by surgery for HPV-associated locoregionally advanced oropharynx cancer. Head Neck. 2020 Aug;42(8):2145-2154. doi: 10.1002/hed.26147. Epub 2020 Mar 25.
- Background: PubMed 31773857Sadeghi N, Khalife S, Mascarella MA, Ramanakumar AV, Richardson K, Joshi AS, Bouganim N, Taheri R, Fuson A, Siegel R. Pathologic response to neoadjuvant chemotherapy in HPV-associated oropharynx cancer. Head Neck. 2020 Mar;42(3):417-425. doi: 10.1002/hed.26022. Epub 2019 Nov 27.
- Background: PubMed 27299983Sadeghi N, Li NW, Taheri MR, Easley S, Siegel RS. Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach. Head Neck. 2016 Dec;38(12):1837-1846. doi: 10.1002/hed.24526. Epub 2016 Jun 14.
- Derived from this study: PubMed 39636629Sadeghi N, Subramaniam T, Richardson K, Mascarella M, Zeitouni A, Shenouda G, Sultanem K, Mlynarek A, Caglar D, Esfahani K, Joshi A, Siegel R, Goodman J, Thakkar P, Lee E, Golabi N, Ramanakumar AV, Hier M, Bouganim N. Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Human Papillomavirus-Related Oropharyngeal Cancer. JAMA Otolaryngol Head Neck Surg. 2025 Feb 1;151(2):128-134. doi: 10.1001/jamaoto.2024.3303.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Beaubien contact
Nader Sadeghi, MD study chair
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel in people with Oropharynx Cancer and Tonsil Cancer, run by Nader Sadeghi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nader Sadeghi, MD (514-934-1934 ext. 34974, nader.sadeghi@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome: progression free survival. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04277858, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.