Simultaneous boost intensity-modulated radiotherapy for locally advanced ce... | Not Recruiting
Simultaneous boost intensity-modula... | Not Recruiting
Simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer
DEPICT

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Medical Conditions
  • Topic: National Cancer Research Network
  • Subtopic: Gynaecological Cancer
  • Disease: Cervix
Primary Contact Details
Recruitment Status
Not Recruiting
Trial source and source ID number
ISRCTN76100993
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
http://www.cancerhelp.org.uk/trials/a-trial-looking-intensity-modulated-radiotherapy-imrt-to-treat-cancer-cervix-depict
Research Details
  • A dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer.
Phase
Sorry, this information is not available
Study Design
Multicentre non-randomised interventional phase I/II treatment trial
Study Type
Interventional
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 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
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned sample size: 44; UK sample size: 44
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 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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
EC1M 6BQ
Trial Contact(s)
Primary Trial Contact
Miss Hanna Nicholas
-
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A phase I/II, multicentre dose escalation study of simultaneous boost intensity-modulated radiotherapy for locally advanced cervical cancer
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) grant (ref: C7925/A10990)
Other Study ID Numbers
7896
Sponsor(s)
Barts and The London NHS Trust (UK)
Key Dates

Recruitment Start Date

22 Jul 2010

Recruitment End Date

31 Jul 2016

Trial Start Date

22 Jul 2010

Trial End Date

31 Jul 2016

Date added to source

21 Oct 2010

Date updated in source

08 Feb 2016