Clinical trial · Interventional
S0713: Oxaliplatin, Capecitabine, Cetuximab, and RT Followed By Surgery in Pts W/Stage II or III Rectal Cancer
A Phase II Study of Oxaliplatin, Capecitabine, Cetuximab and Radiation in Pre-Operative Therapy of Rectal Cancer
- 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 oxaliplatin and capecitabine, 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 chemotherapy 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 II trial is studying the side effects and how well giving oxaliplatin, capecitabine, and cetuximab together with radiation therapy followed by surgery works in treating patients with stage II or stage III 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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| therapeutic surgical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemo + Chemo and radiation + Surgery
- description
- Chemotherapy Cycle 1 (1 cycle is 35 days): * Oxaliplatin, 50 mg/m\^2, IV, Days 1,8,15,22,29 * Cetuximab, 400 mg/m\^2, IV, Day 1 * Cetuximab, 250 mg/m\^2, IV, Days 8,15,22,29 * Capecitabine, 1650 mg/m\^2/day, PO, Monday-Friday (Day 1-35) Chemotherapy+ Radiation Cycle 2: * Oxaliplatin, 50 mg/m\^2, IV, Days 50,57,71,78 * Cetuximab, 250 mg/m\^2, IV, Days 50,57,64,71,78 * Capecitabine, 1650 mg/m\^1, PO, Monday-Friday (Day 50-84) * Radiation therapy: Planning target value 1: 4500 cGy (centigray) in 25 fractions; Planning target value 2 (stage T3 patients): Boost of 540 cGy in 3 fractions; Planning target value 2 (stage T4 patients): Boost of 900 cGy in 5 fractions. Therapeutic Surgical procedure: Resection
- interventionNames
- Biological: cetuximab
- Drug: capecitabine
- Drug: oxaliplatin
- Procedure: therapeutic surgical procedure
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Pathologic Complete Response Rate
- timeFrame
- 15-20 weeks from registration
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy-proven primary adenocarcinoma of the rectum * Stage II or III disease * The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 cm of the anal verge by proctoscopic examination * No recurrent disease * Must have wild-type k-ras status * Measurable and/or nonmeasurable disease PATIENT CHARACTERISTICS: * Zubrod performance status 0-2 * Leukocyte count ≥ 3,000/mcL * Granulocyte count ≥ 1,500/mcL * Platelet count ≥ 100,000/mcL * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * SGOT (serum glutamate oxaloacetate transaminase) or SGPT (serum glutamate pyruvate transaminase)≤ 2.5 times ULN * Creatinine clearance \> 50 mL/min * No prior severe reaction to a monoclonal antibody * Willing to have specimens submitted * No peripheral neuropathy ≥ grade 2 * No known existing uncontrolled coagulopathy * No evidence of current high-grade obstruction * At least 2 weeks since prior diverting procedure * No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol treatment * No prior unanticipated severe reaction to fluoropyrimidine therapy or known sensitivity to fluorouracil or known DPD deficiency * No active inflammatory bowel disease, malabsorption syndrome, or inability to swallow that would impair the ingestion or absorption of capecitabine * No uncontrolled intercurrent illness * No ongoing or active infection * No symptomatic congestive heart failure or unstable angina pectoris * No cardiac arrhythmia or myocardial infarction within the past 12 months * Not pregnant or nursing * Fertile patients must use effective contraception * No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * Recovered from any recent major surgeries (e.g., coronary artery bypass graft, transurethral resection of prostate, or abdominal surgery) * No prior chemotherapy, radiotherapy, or targeted therapy for this tumor * More than 4 weeks since prior investigational agents * No concurrent anti-retroviral therapy for HIV
References
Publications (0)
Data not yet available