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) - EXCITE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-006701-25-GB

Enrollment

Registered

2007-12-20

Start date

2008-02-21

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced rectal cancer MedDRA version: 13.1 Level: PT Classification code 10038049 Term: Rectal cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: PT Classification code 10038050 Term: Rectal cancer stage III System Organ Class: 10029104

Interventions

Trade Name: Erbitux Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMAB CAS Number: 205923564 Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. MRI defined locally advanced rectal cancer: T3 disease on MRI scanning with disease = 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 = 5 cm from the the anal margin 2. Histologically confirmed adenocarcinoma 3. No unequivocal evidence of metastatic disease 4. No pre-existing condition which would deter radiotherapy, e.g. fistulas, severe ulcerative colitis (particularly patients currently taking Sulphasalazine), Crohn’s disease, prior adhesions 5. Estimated GFR (using Cockroft-Gault formula) >50 ml/min. 6. Absolute neutrophil count = 1.5 x 109/l. Platelets = 100 x 109/l, serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Previous chemotherapy. 2. Previous radiotherapy to the pelvis. 3. Patients who have very significant small bowel delineated within the radiation fields should be excluded from the study. 4. Current or impending rectal obstruction, metallic colonic rectal stent in situ 5. Pelvic sepsis 6. Uncontrolled cardiac, respiratory or other disease or any serious medical or psychiatric disorder that would preclude trial therapy, surgery or informed consent. 7. Known dihydropyrimidine dehydrogenase deficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: In a phase II setting in MRI-defined locally advanced rectal cancer to assess the downstaging effectiveness of preoperative chemoradiotherapy using capecitabine/ irinotecan/cetuximab plus radiotherapy using the primary endpoint of clear (R0) circumferential resection margin rate.;Secondary Objective: - Radiotherapy compliance. - Grade 3 or 4 toxicity. - Pathological complete response - Morbidity – post operative and long term. - Disease-free survival and local failure-free survival.;Primary end point(s): The histologically confirmed RO resection rate (proportion of patients with complete macroscopic resection with clear (>1mm) surgical circumferential resection margins)	—

Measure

Time frame

Main Objective: In a phase II setting in MRI-defined locally advanced rectal cancer to assess the downstaging effectiveness of preoperative chemoradiotherapy using capecitabine/ irinotecan/cetuximab plus radiotherapy using the primary endpoint of clear (R0) circumferential resection margin rate.;Secondary Objective: - Radiotherapy compliance. - Grade 3 or 4 toxicity. - Pathological complete response - Morbidity – post operative and long term. - Disease-free survival and local failure-free survival.;Primary end point(s): The histologically confirmed RO resection rate (proportion of patients with complete macroscopic resection with clear (>1mm) surgical circumferential resection margins)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026