Condition category
Cancer
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
08/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.bartsandthelondon.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 08/02/2016 the overall trial end date was changed from 30/04/2013 to 31/07/2016.