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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Locally Advanced Cervical Cancer

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Trial Information

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

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

severe gastrointestinal toxicity assessed according to Common Terminology for Adverse Event Criteria (CTCAE) v 3.0.

Outcome Time Frame:

six months of completing radiotherapy

Safety Issue:


Principal Investigator

Dr Melanie Powell

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barts Health NHS Trust


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

July 2010

Completion Date:

Related Keywords:

  • Locally Advanced Cervical Cancer
  • Cervical Cancer, Intensity-modulated radiotherapy
  • Uterine Cervical Neoplasms