Docetaxel for Oropharyngeal Cancers

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Oropharyngeal Cancers+3 MoreDocetaxel - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying whether chemotherapy followed by surgery is more effective than the current standard of care for oropharyngeal cancer, which is chemo-radiotherapy.

Eligible Conditions
  • Oropharyngeal Cancers
  • Tonsil Cancer
  • Base of the Tongue Cancer
  • Throat Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 5 years

12 months
Head and Neck Specific Quality of Life (QOL)
12 months.
General Quality of Life (QOL)
2 years
: progression free survival.
5 years
Disease Specific Survival (DSS)
Overall Survival (OS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Hypophagia
16%Oedema peripheral
16%Diarrhoea
13%Cough
13%Vomting
13%Alanine aminotransferase increased
13%Neurotoxicity
9%Headache
9%Rash
9%Chest discomfort
9%Anaemia
9%Nausea
9%Bone marrow failure
9%Aspartate aminotransferase increased
9%Musculoskeletal pain
9%Pigmentation disorder
6%Transaminases increased
6%Insomnia
6%Paronychia
6%Flushing
6%Thrombocytopenia
6%Face oedema
6%Nasopharyngitis
6%Mouth ulceration
6%Constipation
3%Completed suicide
3%Cataract
3%Infection
3%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Trial Design

1 Treatment Group

Neoadjuvant chemotherapy and surgery
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Docetaxel · No Placebo Group · Phase 2

Neoadjuvant chemotherapy and surgery
Drug
Experimental Group · 1 Intervention: Docetaxel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
399 Previous Clinical Trials
125,464 Total Patients Enrolled
Nader SadeghiLead Sponsor
Nader Sadeghi, MDStudy ChairMcGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have squamous cell cancer of the oropharynx.
You have a performance status of 60% or less or you have an ECOG score of 2.
You are fit for surgery, and your primary tumor is surgically resectable with negative margins via transoral approach.