Phase 2 Completed N=90 Treatment

Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

Colorectal Cancer

Source: ClinicalTrials.gov NCT00114231 ↗

Enrolled (actual)

Serious AEs

9.5%

Results posted

Mar 2018

Primary outcomePrimary: 3-Year Disease-free Survival — 88.2 percentage of patients

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.

Outcome Measures

Outcome	Result	p-value
PRIMARY 3-Year Disease-free Survival	88.2	—
SECONDARY R0 Resection Rate (Negative Margin Rate)	98.7	—
SECONDARY Morbidity and Mortality Rate	6; 10	—
SECONDARY Rate of Pathologic Complete Response of the Primary Tumor	44	—
SECONDARY Local Recurrence Rate	4	—

Eligibility Criteria

Patient must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod status of = = 3000/mm^3
Absolute neutrophil count (ANC) > 1,500/mm^3
Hemoglobin > 9.5 mg/dl
Platelet count >= 100,000/mm^3
Total bilirubin = = 50 ml/min by Cockroft-Gault equation
Patients who have experienced a prior malignancy must have received potentially curative therapy for that malignancy, and must be cancer-free for at least five years from the date of initial diagnosis (exceptions: patients treated for non-melanoma skin carcinoma, or in-situ carcinomas)
Patients of reproductive potential must agree to use an effective method of birth control when undergoing treatments with known or possible mutagenic or teratogenic effects; all female participants of childbearing potential must have a negative urine or serum pregnancy test within two weeks prior to study registration

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Data sourced from ClinicalTrials.gov (NCT00114231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.