Clinical trial · Interventional
Capecitabine, Irinotecan Hydrochloride, Cetuximab, and Radiation Therapy in Treating Patients Undergoing Surgery for Locally Advanced Rectal Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Histologically confirmed R0 resection rate
- timeFrame
- Week 14 (6 weeks after treatment complete)
Secondary outcomes (7)
- measure
- Radiotherapy compliance
- timeFrame
- Weeks 2, 3, 4, 5 & 6
- description
- Radiotherapy treatment and dosage is captured on weekly CRFs from week 2-6
- measure
- Grade 3 or 4 toxicity as assessed by NCI CTCAE v3.0
- timeFrame
- Baseline, week 1- 10, week 12 & 14 then at 6, 12, 24 & 36 months follow up
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available