Comparing alternative regimens for escalating treatment of intermediate and... | Recruiting
Comparing alternative regimens for ... | Recruiting
Comparing alternative regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
CompARE Trial

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Medical Conditions
  • Topic: Cancer
  • Subtopic: Head and Neck Cancer
  • Disease: Head and Neck
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN41478539
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-different-treatments-for-people-with-oropharyngeal-cancer-compare
Research Details
  • Pragmatic phase III open-label randomised controlled trial using an efficient, adaptive, multi-arm multi-stage (MAMS) design, with an integrated qualitative recruitment investigation aiming to optimise recruitment and consenting, to determine the optimum treatment of intermediate and high-risk OPC with the aim of improving survival outcomes without significantly worsening toxicity, Quality of Life (QoL) or swallowing function, compared to the current standard treatment of chemoradiotherapy.
Phase
Phase III
Study Design
Randomised; Interventional; Design type: Treatment
Study Type
Interventional
Intervention

1. Arm 1: Control arm, concomitant chemoradiotherapy, 3-weekly cisplatin 100mg/m2 or weekly 40mg/m2 with Intensity Modulated Radiotherapy (IMRT) using 70Gy in 35F +/- neck dissection as indicated by clinical and radiological assessment 3-months post treatment. This is the international gold standard.
2. Arm 2: Induction chemotherapy (3 cycles at 3-weekly intervals: Docetaxel 75mg/m2 + Cisplatin 80mg/m2 + 5-Fluorouracil (5-FU) 800mg/m2/day, daily for 4 days), followed by Arm 1.
3. Arm 3: Dose-escalated chemoradiotherapy using intensity modulated radiotherapy (IMRT) 64Gy in 25F + Cisplatin 100mg/m2 day 1 of week 1 and of week 5 or weekly 40mg/m2 (neck dissection as indicated by clinical and radiological assessment at 3-months post-treatment).
4. Arm 4: Resection of primary + selective neck dissection followed by chemoradiotherapy. For T1 & T2 primary tumour, resection must be transoral. For T3 & T4 primary tumour, resection preferably transoral if possible otherwise by open surgery.
Follow Up Length: 24 month(s); Study Entry : Registration and One or More Randomisations

Intervention Type
Drug
Primary Outcome Measures
    1. Definitive (efficacy) endpoint: Overall Survival (OS) - Interval in whole days between the date of randomisation and the date of death from any cause
    2. Interim outcome measure (activity stages): Disease Free Survival (DFS) - Interval between the date of randomisation and the date of death or the 1st documented relapse
Secondary Outcome Measures
    1. Total number of acute (<3 months post-treatment) and late (up to 2 years) severe (grade 3-5) toxicity events at 2 years post randomisation, measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
    2. Overall and head and neck specific QoL at 2 years post randomisation, using the European Organisation for Research and Treatment of Cancer (EORTC) C30 and H&N35 Questionnaires
    3. Swallowing outcomes using M.D. Anderson Dysphagia Inventory (MDADI) Questionnaire at 24 months and percutaneous endoscopic gastrostomy (PEG) utilisation rates at 1 year
    4. Cost effectiveness using EuroQol Group (EQ-5D), patient diaries and primary and secondary resource utilisation data
    5. Surgical complication rates in each arm
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 650; UK Sample Size: 650; Description: Patients with intermediate and high risk oropharyngeal cancer (OPC).
Participant Inclusion Criteria
    1. Oropharyngeal squamous cell carcinoma in base of tongue and tonsil with an Multidisciplinary Team recommendation for treatment with definitive concurrent chemoradiotherapy
    2. Intermediate risk [HPV +ve OPC with N2b+ disease and greater than 10 pack year history of smoking] or high ­risk (HPV–ve OPC) as per Ang classification
    3. Minimum life expectancy of 3 months
    4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    5. Adequate renal function, glomerular filtration rate >50mL/min calculated using Cockcroft­Gault formula
    6. Adequate bone marrow function (absolute neutrophil count ≥1.5 x 109/L and platelets ≥100 x 109/L)
    7. Adequate liver function i.e. plasma bilirubin ≤1.5 times the upper limit of normal, and alanine aminotransferase and Alkaline phosphatase ≤2.5 x upper limit of normal
    8. Prothrombin time ≤1.5 x upper limit of normal or International Normalised Ratio ≤1. 5
    9. Magnesium ≥ lower limit of normal
    10. No cancers in previous 5 years, except basal cell carcinoma of skin and cervical intra­epithelial neoplasia
    11. Age 16-­70
    12. Written informed consent given
    13. Surgically resectable disease if being randomised to all 4 arms
Participant Exclusion Criteria
    1. Low­ risk OPSCC defined as:
    1.1. HPV+ OPC non­smokers or
    1.2. HPV+ OPC smokers <10 pack years or
    1.3. HPV+ OPC smokers >10 pack years with N0­2A nodal disease
    2. Unfit for surgery or chemoradiotherapy regimens
    3. Creatinine Clearance <50ml/min
    4. Treatment with any of the following, prior to first dose of trial treatment:
    4.1. Taxanes
    4.2. Any Investigational Medicinal Products (IMP) within 30 days
    4.3. Any other chemotherapy, immunotherapy or anticancer agents within 3 weeks
    4.4. Major surgery within 4 weeks
    4.5. Radiotherapy:
    4.5.1. With a wide field of radiation or involving >30% of total bone marrow volume, within 4 weeks
    4.5.2. With a limited field of radiation, for palliation, within 2 weeks
    5. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 (with the exception of alopecia) at the time of registration
    6. History of allergic reactions to any of the IMPs used in this trial
    7. Women who are pregnant or breast­feeding. Women of child­bearing potential must have a negative pregnancy test performed within 7 days prior to the start of trial treatment
    8. Men or women who are not prepared to practise methods of contraception of proven efficacy during treatment and for 6 months following the end of treatment
    9. Pre-existing tinnitus or hearing impairment ischaemic heart disease, cerebro­vascular disease, peripheral vascular disease or previous arterial embolic event
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Pfizer Investigational Site
Birmingham
B15 2TT
Trial Contact(s)
Primary Trial Contact
Dr Joshua Savage
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Phase III randomised controlled trial Comparing Alternative REgimens for escalating treatment of intermediate and high-risk oropharyngeal cancer
EudraCT Number
2014-003389-26
Funder(s)
  • Cancer Research UK
Other Study ID Numbers
18621
Sponsor(s)
University of Birmingham
Key Dates

Recruitment Start Date

01 May 2015

Recruitment End Date

01 Nov 2020

Trial Start Date

01 May 2015

Trial End Date

01 Nov 2020

Date added to source

29 Apr 2015

Date updated in source

12 Aug 2015