At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed invasive adenocarcinoma of the rectum (or rectal tumors suspicious for invasion)
- ✓Tumor distal border ≤8 cm from anal verge on endoscopic exam
- ✓uT2uN0 tumor confirmed by ERUS or endorectal coil MRI; greatest diameter ≤4 cm
- ✓ECOG performance status ≤2
- ✕Tumors fixed to adjacent structures on digital exam
- ✕uT1, uT3, or uT4 tumors
- ✕Positive perirectal nodes on ERUS examination
- ✕Histologic evidence of metastatic invasion of inguinal lymph nodes
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer
In Brief
A Phase 2 clinical trial evaluating capecitabine, oxaliplatin, and 2 other interventions for Colorectal Cancer. Completed, enrolled 90 participants across 67 sites.
Detailed 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.
Study Details
Timeline
Interventions
Given IV
Undergo surgery
Undergo radiotherapy