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Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer (EXCITE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University College, London.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
University College, London Identifier:
First received: September 5, 2009
Last updated: December 5, 2014
Last verified: December 2014

RATIONALE: Drugs used in chemotherapy, such as capecitabine and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy, cetuximab, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I/II trial is studying the side effects of giving capecitabine and irinotecan hydrochloride together with cetuximab and radiation therapy and to see how well it works in treating patients undergoing surgery for locally advanced rectal cancer.

Condition Intervention Phase
Rectal Cancer
Biological: cetuximab
Drug: capecitabine
Drug: irinotecan hydrochloride
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EXCITE: Erbitux, Xeloda, Campto, Irradiation Then Excision for Locally Advanced Rectal Cancer (North West Clinical Oncology Group-04 on Behalf of the NCRI Rectal Cancer Subgroup)

Resource links provided by NLM:

Further study details as provided by University College, London:

Primary Outcome Measures:
  • Histologically confirmed R0 resection rate [ Time Frame: Week 14 (6 weeks after treatment complete) ]

Secondary Outcome Measures:
  • Radiotherapy compliance [ Time Frame: Weeks 2, 3, 4, 5 & 6 ]
    Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6

  • Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up ]
    Adverse events are recorded weekly on CRFs from week 1 of treatment until 4 weeks post treatment, then at 1 month post surgery and specified time points during long term follow up at 6, 12, 24 & 36 month intervals.

  • Pathological complete response [ Time Frame: Week 14 (surgery conducted 6 weeks from end of treatment) ]
  • Post-operative morbidity [ Time Frame: Week 14 ]
  • Long-term morbidity [ Time Frame: Week 14, then at 6, 12, 24 & 36 months follow up ]
  • Disease-free survival [ Time Frame: Baseline, week 1- 10, week 12, 14 & then at 6, 12, 24 & 36 months follow up ]
  • Local failure-free survival [ Time Frame: Baseline, weeks 1- 10, weeks 12 & 14 then at 6, 12, 24 & 36 months follow up ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:


  • To assess the downstaging effectiveness and tolerability of neoadjuvant chemoradiotherapy comprising capecitabine, irinotecan hydrochloride, cetuximab, and radiotherapy in patients with locally advanced rectal cancer.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-6 and irinotecan hydrochloride IV over 1 hour once weekly in weeks 2-5. Patients also undergo pelvic radiotherapy once daily and receive oral capecitabine twice daily on days 1-5 in weeks 2-6.

Patients undergo surgery 8 weeks after completion of chemoradiotherapy.

After completion of study treatment, patients are followed up at 6, 12, 24, and 36 months.

Peer Reviewed and Funded or Endorsed by Cancer Research United Kindom (UK).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum
  • MRI-defined locally advanced disease, as defined by 1 of the following:

    • Mesorectal fascia involvement
    • Mesorectal fascia threatened (tumor ≤ 1 mm from mesorectal fascia)
    • Any T3 tumor < 5 cm from anal verge
  • No evidence of metastatic disease


  • ECOG or WHO performance status 0-1
  • ANC ≥ 1.5 x 10^9/L
  • Platelet count ≥ 100 x 10^9/L
  • Serum bilirubin < 1.25 times upper limit of normal (ULN)
  • Serum transaminase(s) < 3 times ULN
  • Serum alkaline phosphatase < 5 times ULN
  • Estimated glomerular filtration rate > 50 mL/min
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Fit to receive all study treatments
  • Able to comply with oral medication
  • No comorbidity or coagulation problem that would deem the patient unsuitable for surgery
  • No pre-existing condition that would preclude radiotherapy (e.g., fistulas, severe ulcerative colitis [particularly patients currently taking sulfasalazine], Crohn's disease, prior adhesions)
  • No current or impending rectal obstruction (unless a defunctioning stoma is present) or metallic colonic rectal stent in situ
  • No significant small bowel delineated within the radiotherapy fields
  • No pelvic sepsis
  • No gastrointestinal disorder that would interfere with oral therapy or oral bioavailability
  • No uncontrolled cardiac, respiratory, or other disease that would preclude study therapy or informed consent
  • No serious medical or psychiatric disorder that would preclude study therapy or informed consent
  • No known dihydropyrimidine dehydrogenase deficiency


  • No prior chemotherapy
  • No prior radiotherapy to the pelvis
  • No concurrent participation in other studies, except genetic studies (e.g., NSCCG-National Study of Colorectal Cancer Genetics)
  • No concurrent St. John wort
  • No other concurrent cytotoxic treatment or radiotherapy
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Please refer to this study by its identifier: NCT00972881

United Kingdom
Yorkshire Regional Clinical Trials & Research Unit
Leeds, England, United Kingdom, LS16 6QB
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Rosemere Cancer Centre at Royal Preston Hospital
Preston, England, United Kingdom, PR2 9HT
Cancer Research UK and University College London Cancer Trials Centre
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Sponsors and Collaborators
University College, London
Principal Investigator: Simon Gollins, MD Glan Clwyd Hospital
  More Information

Responsible Party: University College, London Identifier: NCT00972881     History of Changes
Other Study ID Numbers: CDR0000648171
Study First Received: September 5, 2009
Last Updated: December 5, 2014

Keywords provided by University College, London:
adenocarcinoma of the rectum
Locally advanced rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites processed this record on April 25, 2017