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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972881
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
University College, London

Brief Summary:

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

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

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

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

  2. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00972881

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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
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Principal Investigator: Simon Gollins, MD Glan Clwyd Hospital
Additional Information:
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Responsible Party: University College, London Identifier: NCT00972881    
Other Study ID Numbers: CDR0000648171
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: December 2014
Keywords provided by University College, London:
adenocarcinoma of the rectum
Locally advanced rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological