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

Phase 1

Completed

• Conditions: Locally Advanced Cervical Cancer
• Interventions: Drug: Cisplatin; Radiation: Intensity-modulated radiation therapy; Procedure: Intracavitary brachytherapy

• Registration Number: NCT01230996
• Lead Sponsor: Barts & The London NHS Trust

Brief 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

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-28
• Study First Submitted QC: 2010-10-28
• Study First Posted: 2010-10-29
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation study	Intracavitary brachytherapy	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).
Dose escalation study	Intensity-modulated radiation therapy	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).
Dose escalation study	Cisplatin	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).

Primary Outcome Measures

Name	Time	Method
Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0	6 months

Secondary Outcome Measures

Name	Time	Method
Response rate assessed radiologically at 3 and 12 months	3 and 12 months
Local control of the disease at 2 years	2 years
Late toxicity at 2 years as defined by CTCAE v 3.0	2 years

Trial Locations

Locations (4)

Saint Bartholomew's Hospital; 🇬🇧 London, England, United Kingdom

Hammersmith Hospital; 🇬🇧 London, England, United Kingdom

Royal Marsden - London; 🇬🇧 London, England, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, United Kingdom