Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer

Locally Advanced Cervical Cancer Clinical Trial

— DEPICT  

Official title:

A Phase I/II, Multi-centre Dose Escalation Study of Simultaneous Boost Intensity-modulated Radiotherapy for Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01793701
• Other study ID #: 6883
• Secondary ID: 2843509/H0706/90
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: February 14, 2013
• Last updated: August 25, 2017
• Start date: July 2010
• Est. completion date: April 2018

Study information

• Verified date: August 2017
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: April 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

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.

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Hammersmith Hospital	London
United Kingdom	Royal Marsden	London
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (3)

Lead Sponsor	Collaborator
Queen Mary University of London	Barts & The London NHS Trust, Barts Cancer Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0.		six months of completing radiotherapy
Secondary	Objective tumour response rate		6 months
Secondary	2 year local control rate		2 years

External Links

•   Cancer Help - CRUK