Condition category
Cancer
Date applied
16/01/2017
Date assigned
23/01/2017
Last edited
24/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mrs Georgina Gardner

ORCID ID

Contact details

Wales Cancer Trials Unit
Centre for Trials Research
Cardiff University
6th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 29 2068 7950
VIM@Cardiff.ac.uk

Additional identifiers

EudraCT number

2014-001992-30

ClinicalTrials.gov number

Protocol/serial number

32185

Study information

Scientific title

A randomised controlled phase II trial of oral vinorelbine as second line therapy for patients with malignant pleural mesothelioma

Acronym

VIM

Study hypothesis

The aim of this study it to establish whether treatment with vinorelbine in patients with malignant pleural mesothelioma (MPM) actually makes them live longer.

Ethics approval

Wales REC 3, 22/10/2014, ref: 14/WA/1054

Study design

Randomised; Interventional; Design type: Treatment, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Cancer, Primary sub-specialty: Lung Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs

Intervention

Participants will be randomised (1:2) to receive either active symptom control (ASC) or ASC with vinorelbine. Participant randomisation will be performed centrally by the WCTU.

Group A: Participants receive active supportive care only for the duration of the study. Active supportive care is defined as the treatments and procedures used locally to control the symptoms of mesothelioma. Examples of symptoms and possible treatments are listed below, but this list is not exhaustive and any supportive treatment may be classed as ASC.
Breathlessness: Chest drain, relaxation, posture advice, medication, anti-anxiety medication, oxygen
Pain Painkillers, relaxation, massage, referral to specialist pain clinics
Night sweats: Management advice, medication
Loss of appetite: High protein powders/high calorie drinks, steroids, nutritional advice, supplements
Tiredness: Sleep advice, gentle exercise
Anaemia: Blood transfusion
Depression: Counselling, anti-depressants
Other: Acupuncture, massage, aromatherapy and relaxation technique

Group B: Patients will be treated with ASC as above, plus vinorelbine. Vinorelbine (Navelbine) should be administered at a dose of 60mg/m2 orally weekly for the first cycle (days 1, 8 and 15) on a 3-weekly cycle. Subsequent doses should be increased to 80mg/m2 (day 22) if there has been no haematological toxicity. Patients remain on ASC or treatment until disease progression (or unacceptable toxicity or patient withdrawal).

There will be a follow-up assessment at disease progression/End of treatment (Arm B only) and follow-up assessment 30 days after disease progression/End of treatment (Arm B only). Trial follow-up will continue for 18 months after the last participant is randomised.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Overall survival will be measured as time from randomisation to death (from any cause).

Secondary outcome measures

1. Progression free survival is assessed by modified RECIST using baseline CT scan results compared against further CT scans on Day 1 of each cycle of treatment
2. Safety and tolerability and feasibility of use will be assessed during and after treatment by collection of toxicities according to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 at every clinic visit and reporting of SAEs in real-time
3. Objective response rate as assessed by modified RECIST using baseline CT scan results compared against further CT scans on Day 1 of each cycle of treatment

Overall trial start date

11/09/2013

Overall trial end date

01/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Confirmed histological diagnosis of malignant pleural mesothelioma. The same block or 10 unstained slides should be available for translational research
2. Prior treatment with first-line standard platinum doublet based chemotherapy. Re-challenge with first line chemotherapy is allowed.
3. Evidence of disease progression according to CT scan on Modified RECIST
4. Life expectancy ≥ 3 months
5. ECOG performance status 0-1
6. Men or women aged 18 years or over
7. Willing to consent to provide blood and tissue for translational research
8. Disease which is measurable using modified RECIST
9. Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, WBC ≥3 x 109/L, haemoglobin ≥ 100g/L, platelets ≥ 100 x 109/L; adequate liver function: Bilirubin < 1.5 x ULN AST/ALT < 1.5- 2.5 x ULN.
10. Patients with reproductive potential (male or female), who are sexually active during the duration of the trial or the drug washout period, should be prepared to use two effective forms of contraception throughout their participation in the trial and for at least three months after the last dose of vinorelbine. Effective forms of contraception would include condom with spermicide, along with one of the following: oral contraceptive or hormonal therapy (e.g. hormone implants); placement of an inter-uterine device; vasectomy with assurance of post- vasectomy confirmation of azoospermia; tubal occlusion. Accepted hormonal methods include: Etonogestrel implants; normal and low dose combined oral pills; orelgestromin/ethinyl estradiol transdermal system; or desogestrel.
11. Patients must provide informed consent before any study specific procedures

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 200; UK Sample Size: 200

Participant exclusion criteria

1. Patients with a diagnosis of a second malignancy except prostate or cervical cancer in remission or patients with a diagnosis of basal cell carcinoma of the skin
2. Have received treatment with an agent that has no marketing authorisation, within 30 days of study entry
3. Are pregnant or breastfeeding. If a participant becomes pregnant during the trial, and is randomised to the treatment arm, vinorelbine must be discontinued and the participant followed up until birth or termination of pregnancy. Breastfeeding must be avoided as it is unknown whether vinorelbine is excreted in human milk.
4. Uncontrolled CNS disease
5. Known contraindication or hypersensitivity to vinorelbine or other vinca alkaloids or to any of the constituents
6. Any disease significantly affecting absorption
7. Previous significant surgical resection of stomach or small bowel
8. Yellow fever vaccine within 30 days of consent
9. Previous vinca alkaloid chemotherapy
10. Palliative radiotherapy within the RECIST area in the 4 weeks prior to baseline CT chest up until randomisation.
11. Patients that are unable to swallow

Recruitment start date

01/03/2016

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Trial participating centre

Velindre NHS Trust
Velindre Road Whitchurch
Cardiff
CF14 2TL
United Kingdom

Trial participating centre

Churchill Hospital
Old Road Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

University of Leicester

Sponsor details

Research Governance Office
Fielding Johnson Building
Leicester
LE1 7RH
United Kingdom
+44 116 373 6410/223 1660
uolsponsor@leicester.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/10/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates. 10/04/2017: Link to Cancer Help UK lay summary added to plain English Summary field