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 designMulticentre non-randomised interventional phase I/II treatment trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA phase I/II, multicentre dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer
Study acronymDEPICT
Study objectivesA 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) studiedTopic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Cervix
InterventionBrief 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 typeMixed
Primary outcome measureSevere gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0, measured within six months of completing radiotherapy
Secondary outcome measures1. Objective tumour response rate, measured at 6 months
2. Two year local control rate, measured at 2 years
Overall study start date22/07/2010
Completion date31/07/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 44; UK sample size: 44
Key inclusion criteria1. 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 criteria1. 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 enrolment22/07/2010
Date of final enrolment31/07/2016

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.