Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer
Conditions
Locally Advanced Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical Cancer, Intensity-modulated radiotherapy
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: intensity modulated radiotherapy Type: Radiation
Name: Intracavitary brachytherapy Type: Procedure
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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.
Detailed Description
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Locations
Barts Health NHS Trust
London, United Kingdom
Status: Recruiting
Contact: Sofia Fernandes, MSc - 0044(0)2078828487 - depict@qmcr.qmul.ac.uk
Hammersmith Hospital
London, United Kingdom
Status: Recruiting
Royal Marsden
London, United Kingdom
Status: Recruiting
Start Date
July 2010
Sponsors
Queen Mary University of London
Source
Queen Mary University of London
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page