Simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer
| ISRCTN | ISRCTN76100993 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76100993 |
| ClinicalTrials.gov (NCT) | NCT01230996 |
| Protocol serial number | 7896 |
| Sponsor | Barts and The London NHS Trust (UK) |
| Funder | Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C7925/A10990) |
- 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
Contact information
Miss Hanna Nicholas
Scientific
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre non-randomised interventional phase I/II treatment trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
Severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0, measured within six months of completing radiotherapy |
| Key secondary outcome measure(s) |
1. Objective tumour response rate, measured at 6 months |
| Completion date | 31/07/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Barts and The London NHS Trust
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
