Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Miss Hanna Nicholas
ORCID ID
Contact details
Barts and The London NHS Trust
School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom
-
h.nicholas@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7896
Study information
Scientific title
A phase I/II, multicentre dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer
Acronym
DEPICT
Study hypothesis
A dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer.
Ethics approval
Riverside Research Ethics Committee, 07/12/2009, ref: 09/H0706/90
Study design
Multicentre non-randomised interventional phase I/II treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Cervix
Intervention
Brief summary:
This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer. Following screening to confirm eligibility patients will commence a six week treatment period. After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years). End of study is defined as 24 months after treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.
Study design:
Primary Purpose: Treatment
Study Phase: Phase I/II
Intervention Model: Single Group Assignment
Number of Arms: One
Masking: Open Label
Allocation: N/A
Enrolment: 44
Interventions:
Integrated boost intensity-modulated radiotherapy (IMRT) once a day for treatment (Monday to Friday) over 6 weeks. Each treatment lasts for approximately 10 minutes. Chemotherapy: weekly cisplatin
Sequencing: Radiotherapy 30 minutes - one hour after completing cisplatin infusion. Weekly cisplatin for up to 5 weeks concomitantly with radiotherapy
Dose: Cisplatin 40 mg/m^2 (maximum 75 mg) in 1 litre of normal saline over an hour.
Pre-hydration and post-hydration: according to local practice. Magnesium supplement is recommended in the hydration.
Follow up length: 24 months
Study entry: registration only
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
Severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0, measured within six months of completing radiotherapy
Secondary outcome measures
1. Objective tumour response rate, measured at 6 months
2. Two year local control rate, measured at 2 years
Overall trial start date
22/07/2010
Overall trial end date
31/07/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix
2. International Federation of Gynecology and Obstetrics (FIGO) stage IIB - IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement
3. Measurable disease on magnetic resonance imaging (MRI)
4. Aged greater than 18 years (no upper limit), either sex
5. World Health Organisation (WHO) performance status 0 or 1
6. Adequate renal function with ethylenediaminetetraacetic acid (EDTA) clearance greater than 55 ml/min
7. Adequate liver function, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 upper limit of normal (ULN), and bilirubin less than 1.25 ULN
8. Adequate bone marrow function, defined by white cell count (WCC) greater than 3.0 x 10^9/litre, neutrophils greater than 1.5 x 10^9/litre and platelets greater than 100 x 10^9 /litre
9. Able to understand and give written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 44; UK sample size: 44
Participant exclusion criteria
1. Evidence of common iliac or para-aortic nodal involvement, or distant metastases
2. Previous history of cancer except skin tumour
3. Previous pelvic radiotherapy or surgery other than toparoscopic node disection
4. Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus
5. Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus
6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy if required. Acceptable contraception should be used such as barrier or hormonal methods.
7. Females must not be pregnant or breastfeeding
Recruitment start date
22/07/2010
Recruitment end date
31/07/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barts and The London NHS Trust
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Barts and The London NHS Trust (UK)
Sponsor details
School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
E1 8PR
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C7925/A10990)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list