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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

Thank you

Trial Information

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)


OBJECTIVES:

- 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).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histologically confirmed R0 resection rate

Outcome Time Frame:

Week 14 (6 weeks after treatment complete)

Safety Issue:

No

Principal Investigator

Simon Gollins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Glan Clwyd Hospital

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

CDR0000648171

NCT ID:

NCT00972881

Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Rectal Cancer
  • adenocarcinoma of the rectum
  • Locally advanced rectal cancer
  • Rectal Neoplasms

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