Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Locally Advanced Cervical Cancer |
Radiation: intensity modulated radiotherapy Procedure: Intracavitary brachytherapy Drug: Cisplatin |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Multi-centre Dose Escalation Study of Simultaneous Boost Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer |
- severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0. [ Time Frame: six months of completing radiotherapy ] [ Designated as safety issue: Yes ]
- Objective tumour response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 2 year local control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
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.
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Detailed Description:
Primary objective
- To determine the feasibility of dose escalation with simultaneous boost intensity-modulated radiotherapy (IMRT) in locally advanced cervical cancer
Secondary Objectives
- To assess objective response rates
- To assess local control
- To correlate toxicity with dose-volume histogram data
Primary endpoint
- Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v3.0 (Common Terminology for Adverse Events)
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix
- FIGO stage IIB-IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement
- Measurable disease on MRI
- Age > 18 years (no upper limit)
- WHO performance status 0,1
- Adequate renal function with EDTA clearance> 55ml/min
- Adequate liver function, as defined by ALT or AST less than 2.5 x ULN, and bilirubin less than 1.25 x ULN
- Adequate bone marrow function, defined by WCC >3.0 x 109/litre, neutrophils > 1.5 x 109/litre and platelets > 100 x 109 /litre
- Able to understand and give written informed consent
Exclusion Criteria:
- Evidence of common iliac or para-aortic nodal involvement, or distant metastases
- Previous history of cancer except skin tumour
- Previous pelvic radiotherapy or surgery other than toparoscopic node disection
- Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus
- 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.
- Females must not be pregnant or breastfeeding
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| Contact: Sofia Fernandes | 0044(0)2078828487 | depict@qmcr.qmul.ac.uk |
| United Kingdom | |
| Barts Health NHS Trust | Recruiting |
| London, United Kingdom | |
| Contact: Sofia Fernandes, MSc 0044(0)2078828487 depict@qmcr.qmul.ac.uk | |
| Principal Investigator: Dr Melanie Powell | |
| Royal Marsden | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Dr Susan Lalondrelle | |
| Hammersmith Hospital | Recruiting |
| London, United Kingdom | |
| Principal Investigator: Dr Steven Mangar | |
| Principal Investigator: | Dr Melanie Powell | Barts Health NHS Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | Centre of Experimental Medicine, Dr Melanie Powell, Queen Mary University of London |
| ClinicalTrials.gov Identifier: | NCT01793701 History of Changes |
| Other Study ID Numbers: | 6883, 28435, 09/H0706/90 |
| Study First Received: | February 14, 2013 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Queen Mary University of London:
|
Cervical Cancer, Intensity-modulated radiotherapy |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |
Genital Diseases, Female Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013