Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer

Locally Advanced Cervical Cancer Clinical Trial

— DEPICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230996
• Other study ID #: 6867
• Secondary ID: ISRCTN76100993
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2010
• Est. completion date: July 2018

Study information

• Verified date: April 2019
• Source: Barts & The London NHS Trust
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Radiation:
• Intensity-modulated radiation therapy
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 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.

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London	England
United Kingdom	Royal Marsden - London	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0		6 months
Secondary	Response rate assessed radiologically at 3 and 12 months		3 and 12 months
Secondary	Local control of the disease at 2 years		2 years
Secondary	Late toxicity at 2 years as defined by CTCAE v 3.0		2 years