Simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer

ISRCTN	ISRCTN76100993
DOI	https://doi.org/10.1186/ISRCTN76100993
ClinicalTrials.gov number	NCT01230996
Secondary identifying numbers	7896

Submission date: 21/10/2010
Registration date: 21/10/2010
Last edited: 06/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-intensity-modulated-radiotherapy-imrt-to-treat-cancer-cervix-depict

Contact information

Miss Hanna Nicholas
Scientific

Barts and The London NHS Trust
School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Email	h.nicholas@qmul.ac.uk

Study information

Study design	Multicentre non-randomised interventional phase I/II treatment trial
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A phase I/II, multicentre dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer
Study acronym	DEPICT
Study objectives	A dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer.
Ethics approval(s)	Riverside Research Ethics Committee, 07/12/2009, ref: 09/H0706/90
Health condition(s) or problem(s) studied	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
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 study start date	22/07/2010
Completion date	31/07/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 44; UK sample size: 44
Key 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
Key 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
Date of first enrolment	22/07/2010
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Barts and The London NHS Trust

London
EC1M 6BQ
United Kingdom

Sponsor information

Barts and The London NHS Trust (UK)
Hospital/treatment centre

School of Medicine and Dentistry
Rutland Place
Charterhouse Square
London
E1 8PR
England
United Kingdom

Website	http://www.bartsandthelondon.nhs.uk
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C7925/A10990)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

06/09/2019: ClinicalTrials.gov number added. No publications found, verifying study status with principal investigator.
08/02/2016: The overall trial end date was changed from 30/04/2013 to 31/07/2016.