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Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01793701
First Posted: February 15, 2013
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Barts & The London NHS Trust
Barts Cancer Institute
Information provided by (Responsible Party):
Centre of Experimental Medicine, Queen Mary University of London
February 14, 2013
February 15, 2013
August 28, 2017
July 2010
April 2016   (Final data collection date for primary outcome measure)
severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0. [ Time Frame: six months of completing radiotherapy ]
Same as current
Complete list of historical versions of study NCT01793701 on ClinicalTrials.gov Archive Site
  • Objective tumour response rate [ Time Frame: 6 months ]
  • 2 year local control rate [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer
A Phase I/II, Multi-centre Dose Escalation Study of Simultaneous Boost Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer
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.
  1. Primary objective

    - To determine the feasibility of dose escalation with simultaneous boost intensity-modulated radiotherapy (IMRT) in locally advanced cervical cancer

  2. Secondary Objectives

    • To assess objective response rates
    • To assess local control
    • To correlate toxicity with dose-volume histogram data
  3. Primary endpoint

    - Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v3.0 (Common Terminology for Adverse Events)

  4. Secondary endpoints

    • Response rate assessed radiologically at 3 months and 12 months
    • Local control at 2 years
    • Late toxicity at 2 years as defined by CTCAE v3.0
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Locally Advanced Cervical Cancer
  • Radiation: intensity modulated radiotherapy

    Patients in this trial will receive radiotherapy to the pelvic area with additional chemotherapy (chemoradiotherapy).

    This is the standard treatment for cervix cancer and will be almost identical to patients not taking part in this study. As patients in the study will be treated with IMRT, the total radiation dose will be slightly higher but without increasing the dose to normal tissue in the pelvis. This will mean the number of radiotherapy treatments that each patient receives in the study is between 27 and 30 compared with the usual 28. Each patient will undergo 6 weeks of radiotherapy treatment and must attend the radiotherapy department hospital once daily (Monday to Friday) over 6 weeks. Each treatment lasts for approximately 10 15 minutes. This is exactly the same as standard practice if patients were not participating in the trial.

    Other Name: IMRT
  • Procedure: Intracavitary brachytherapy
    Intracavitary brachytherapy will be given towards the end of external beam radiotherapy usually weeks five and six. This is routine treatment and will be given according to local practice As is the convention patients will be reviewed weekly (more frequently if necessary) by their study doctor and will have weekly blood tests to measure full blood count and urea and electrolytes
  • Drug: Cisplatin
    Each patient will also receive chemotherapy with a drug called cisplatin, which is given intravenously through a drip in the arm once a week during their 6 week radiotherapy treatment. Again this is standard treatment for any patient with cervix cancer.
Experimental: Dose escalation study
This is a dose escalation study of IMRT for women with locally advanced cervical cancer. Three dose levels will be investigated, (although, the first dose level is considered to be the equivalent to a standard pelvic dose with parametrial boost). Before moving to the next dose level it must be confirmed by the Chief Investigator that the Maximum Administrable Dose (MAD) has not been met in the previous dose level (see section 6.3). If MAD is reached before dose level 3 the study will stop. All patients enrolled on the study will undergo the same procedures at the same time points, regardless of the dose level they are being given (see section 5).
Interventions:
  • Radiation: intensity modulated radiotherapy
  • Procedure: Intracavitary brachytherapy
  • Drug: Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
22
April 2018
April 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix
  2. FIGO stage IIB-IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement
  3. Measurable disease on MRI
  4. Age > 18 years (no upper limit)
  5. WHO performance status 0,1
  6. Adequate renal function with EDTA clearance> 55ml/min
  7. Adequate liver function, as defined by ALT or AST less than 2.5 x ULN, and bilirubin less than 1.25 x ULN
  8. Adequate bone marrow function, defined by WCC >3.0 x 109/litre, neutrophils > 1.5 x 109/litre and platelets > 100 x 109 /litre
  9. Able to understand and give written informed consent

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. 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.
  6. Females must not be pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01793701
6883
28435 ( Other Grant/Funding Number: NIHR CSP LCRN funded )
09/H0706/90 ( Other Identifier: Riverside Research Ethics Committee )
No
Not Provided
Not Provided
Centre of Experimental Medicine, Queen Mary University of London
Queen Mary University of London
  • Barts & The London NHS Trust
  • Barts Cancer Institute
Principal Investigator: Dr Melanie Powell Barts & The London NHS Trust
Queen Mary University of London
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP