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

Contact information



Primary contact

Mr Arwel Lloyd


Contact details

North Wales Cancer Treatment Centre
Ysbyty Glan Clwyd
Rhuddlan Road
LL18 5UJ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A phase I/II study of Radiotherapy, Irinotecan, Capecitabine then Excision for locally advanced rectal cancer



Study hypothesis

Phase I/II study. Phase I investigated the safety of preoperative neoadjuvant chemoradiation using radiotherapy combined with concurrent capecitabine and irinotecan for locally advanced rectal cancer before surgery, determining the recommended dose.

Phase II of the study then used the recommended dose to assess the histological downstaging efficacy of this chemoradiation regimen, together with assessment of long-term survival end points and late radiation morbidity.

Ethics approval

First MREC approved on the 18th March 2004 (ref: 04/4/015)

Study design

Multicentre non-randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

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: Colorectal Cancer; Disease: Rectum


Capecitabine: orally at 650 mg/m^2 twice daily (b.d.) throughout radiotherapy including weekends
Irinotecan: 60 mg/m^2 intravenous (IV) once per week during the first 4 weeks of radiotherapy
Radiotherapy: 45 Gy in 25 daily fractions over 5 weeks

Follow-up length: 36 months

Intervention type



Phase II

Drug names

Irinotecan, capecitabine

Primary outcome measure

1. Determine safety and recommended dose of combination of radiotherapy, capecitabine and irinotecan (phase I only)
2. Histological pathological complete response rate (phase II only)

Secondary outcome measures

1. Long-term survival outcomes (phase II only)
2. Assessment of late morbidity (phase II only)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Written informed consent given to participate in the trial
2. Male or female patients aged greater than or equal to 18 years old
3. World Health Organization (WHO) performance status 0, 1 or 2
4. Histologically confirmed previously-untreated carcinoma of the rectum with distal extent within 12 cm of the anal verge using a rigid sigmoidoscope
5. Deemed to be a candidate for preoperative downstaging chemoradiation due to: T3 disease on magnetic resonance imaging (MRI) scanning with disease less than or equal to 2 mm from the edge of the mesorectum or T4 disease on MRI scanning or any T3/T4 disease on MRI scanning with the distal extent of tumour less than or equal to 5 cm from the the anal margin
6. Adequate haematology: Neutrophil count greater than 1.5 x 10^9/l, platelet count greater than 100 x 10^9/l, Hb greater than 9 g/dl. The use of blood transfusions is allowed.
7. Adequate renal and hepatic function: serum creatinine = 1.5 x upper limit of normal (ULN), serum bilirubin = 1.25 x ULN, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase = 2.5 x ULN

Participant type


Age group




Target number of participants

Planned sample size: 142; UK sample size: 142

Participant exclusion criteria

1. Previous systemic chemotherapy
2. Previous radiotherapy to the planned exposure area
3. Those unfit for resection because of metastases
4. Any severe concurrent medical condition which would make it undesirable, in the clinician's opinion, for the patient to participate in the trial or which would jeopardise compliance with the trial protocol
5. Patients with a calculated creatinine clearance of less than 50 ml/min
6. Patients with loss of continuity of the upper gastrointestinal (GI) tract or malabsorbtion
7. Patients who have suffered a myocardial infarction within last year and/or have unstable angina, arrythmia or cardiac failure
8. Pregnancy or lactation. Patients of child bearing potential not implementing adequate contraception.
9. Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin
10. Subjects considered by the investigator to be at risk of transmitting any infection through blood or other body fluid including Acquired Immune Deficiency Syndrome (AIDS), or other sexually transmitted disease or hepatitis
11. Patient participation in other studies
12. Partial or complete bowel obstruction (though patients in whom this has been relieved with a defunctioning stoma, are permitted to enter the trial)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

North Wales Cancer Treatment Centre
LL18 5UJ
United Kingdom

Sponsor information


Conwy and Denbighshire NHS Trust (UK)

Sponsor details

Glan Clwyd District Hospital
LL18 5UJ
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Pfizer Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Roche Ltd (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

Basic results (scientific)

Publication list

2009 results in

Publication citations

  1. Results

    Gollins SW, Myint S, Susnerwala S, Haylock B, Wise M, Topham C, Samuel L, Swindell R, Morris J, Mason L, Levine E, Preoperative downstaging chemoradiation with concurrent irinotecan and capecitabine in MRI-defined locally advanced rectal cancer: a phase I trial (NWCOG-2)., Br. J. Cancer, 2009, 101, 6, 924-934, doi: 10.1038/sj.bjc.6605258.

Additional files

Editorial Notes