Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Mandy Feeney


Contact details

Cancer Research UK and UCL Cancer Trials Centre
90 Tottenham Court Road
United Kingdom

Additional identifiers

EudraCT number

2005-000134-20 number

Protocol/serial number


Study information

Scientific title

Phase II non-randomised interventional treatment study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer



Study hypothesis

For the past 10 years cisplatin-based chemoradiation (CRT) has been the treatment of choice for all patients with locally advanced cervical cancer. The key CRT trials showed a reduction in the risk of death by 30 - 50% with an absolute improvement in 5 year survival of 12%. However, a large proportion of patients in these trials had early stage disease (stage I, II) so the results may not be broadly applicable to women with more advanced disease/large tumours, or positive nodes. The outlook for such patients remains poor and new approaches are needed.

To date, trials addressing the role of neoadjuvant chemotherapy (NACT) have generated conflicting data. Although a meta-analysis of 21 randomised trials failed to show any overall improvement in survival with NACT, an association between outcome and cycle length has been observed. Trials with a cycle length of 14 days or less were associated with an improvement in survival of approximately 7% at 5 years, while longer cycle lengths had a detrimental effect on outcome.

Therefore, it is postulated that a short course of dose dense NACT with weekly cycles of treatment prior to definitive CRT might downstage the tumours, lengthen the exposure to systemic treatment and improve outcome. Several cytotoxic agents have shown activity in cervical cancer, however very few of these agents have been tested in the weekly setting. This phase II study will assess the use of neoadjuvant weekly paclitaxel and carboplatin chemotherapy followed by concomitant chemoradiation in 50 patients with locally advanced cervical cancer.

Ethics approval

Cambridgeshire 1 Research Ethics Committee approved on the 17/05/2005 (ref: 04/Q0104/163)

Study design

Non-randomised interventional treatment trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Cervix


Neoadjuvant chemotherapy:
Weekly treatment for six weeks: paclitaxel (80 mg/m^2 IV) followed by carboplatin AUC2 IV on days 1, 8, 15, 22, 29 and 36.

Cisplatin: 40 mg/m^2 (maximum 70 mg) weekly for 6 weeks maximum, commencing in week 7 of treatment regimen (or as soon as blood counts have recovered).
Pelvic radiotherapy: 50.4 Gy in 28# over 5.5 weeks
High dose rate brachytherapy: 14 Gy in 2# (1 or 2 intracavitary insertions)
Pelvic sidewall boost (unilateral or bilateral) for all patients FIGO stage IIb and above with parametrial/pelvic sidewall disease extension, 5.4 Gy in 3# over 3 days.

Patient follow-up after treatment: 3 monthly for 2 years
Study entry: registration only

Intervention type



Phase II

Drug names


Primary outcome measures

Overall response to both the neoadjuvant combination chemotherapy and the concomitant chemoradiotherapy. 6 week assessment after neoadjuvant chemotherapy by clinical examination and MRI pelvis according to RECIST; 12 week assessment after concomitant chemoradiotherapy by clinical examination, MRI pelvis and CT abdomen by RECIST.

Secondary outcome measures

1. Response rate to neoadjuvant chemotherapy
2. The toxicity of neoadjuvant weekly paclitaxel and carboplatin chemotherapy, as defined by Common Toxicity Criteria (CTC)
3. Overall survival
4. Progression free survival

Patients will be followed 3 monthly for two years, patients will be evaluated clinically and toxicity assessed.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Histologically confirmed and reviewed at the cancer centre International Federation of Gynaecology and Obstetrics (FIGO) stage Ib2 - IVa squamous, adeno-, or adenosquamous carcinoma of the cervix suitable for radical chemoradiation
2. EUA, cystoscopy and sigmoidoscopy performed by Gynaecological Oncologist +/- Clinical Oncologist to confirm FIGO stage with biopsy of any suspicious lesions in bladder, vagina or rectum
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
4. Age over 18, no upper limit, providing patient deemed fit by supervising oncologist to receive chemoradiation
5. Adequate renal function, as defined by glomerular filtration rate (GFR) estimated by EDTA or creatinine clearance (24 hour urine) greater than or equal to 60 ml/min
6. Adequate liver function, as defined by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 2.5 upper limit of normal (ULN), and bilirubin less than 1.25 ULN
7. Adequate bone marrow function, as defined by white cell count (WCC) greater than 3.0 x 10^9/litre, neutrophils greater than 1.5 x 10^9/litre, and platelets greater than 100 x 10^9/litre
8. Placement of ureteric stents in all patients with hydronephrosis regardless of renal function
9. Normal electrocardiogram (ECG)
10. Written informed consent

Participant type


Age group




Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Pregnant or breast feeding patients
2. Previous diagnosis of cancer, except basal cell carcinoma (BCC) skin
3. Active cardiac disease

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK and UCL Cancer Trials Centre
United Kingdom

Sponsor information


University College London (UK)

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name

University College London Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in

Publication citations

Additional files

Editorial Notes

27/11/2015: Publication reference added.