Clinical trial · Interventional
Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer
A Phase II Open-labeled, Prospective Study to Determine the Efficacy of Preoperative Chemoradiation With Oxaliplatin/5-FU in Locally Advanced Rectal Cancer Followed by Total Mesorectal Excision and FOLFOX6
- 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: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved outcomes. The addition of oxaliplatin (OXA) to neoadjuvant therapy may reduce distant disease recurrence. Adjuvant treatment with OXA for rectal cancer has been motivated by benefits demonstrated in stage III colon cancer. Objective: To determine the feasibility, toxicity, and efficacy of preoperative OXA/5FU and RT followed by total mesorectal excision (TME) and adjuvant PURPOSE: This phase II trial is studying the side effects and how well giving neo-adjuvant combination chemotherapy with radiation works in treating patients undergoing surgery for 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| leucovorin | Drug | Leucovorin | ALIAS |
| mesorectal excision | Procedure | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative Chemoradiation
- description
- Preoperative Chemoradiation with oxaliplatin/5-FU followed by mesorectal excision and 5-FU / leucovorin (FOLFOX 6)
- interventionNames
- Drug: 5-FU
- Drug: Oxaliplatin
- Drug: leucovorin
- Procedure: mesorectal excision
Primary outcomes (1)
- measure
- Pathologic Response and Complete Response
- timeFrame
- Total mesorectal excision (TME) participants were evaluated at the time of surgical resection, an average of 3.5 months
- description
- Pathologic Response and Complete Response to preoperative therapy will be determined at the time of surgical resection. All grossly visible areas of ulceration and/or induration with be measured and submitted for histological evaluation. The unit of measure is the tumor response rate to preoperative chemoradiation. Pathologic complete response (pCR) is defined as no evidence of invasive tumor cells on pathologic examination of the primary rectal cancer. Tumor regression grade (TRG) will be quantitated into five grades: TRG 1 (complete regression) -absence of residual cancer and fibrosis extending from the site of original tumor through the layers of the rectal wall. TRG 2 characterized by the presence of rare residual cancer cells scattered through the fibrosis. TRG 3 characterized by an increase in the number of residual cancer cells, but fibrosis still predominant. TRG 4 -residual cancer outgrowing fibrosis. TRG 5 characterized by absence of regressive changes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically proven adenocarcinoma of the rectum with no distant metastases. * T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT * The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination. * No prior chemotherapy or pelvic irradiation. * ECOG performance status 0-1 * Age 18 to 70 years * ANC \>= 1500/mm3 and platelets \>= 100,000/mm3 * Serum creatinine \<= 1.5 x ULN; bilirubin \<= 1.5 x ULN; ALT\<= 2.5 x ULN Exclusion Criteria * Pregnant or lactating females; patients not practicing active contraception while sexually active. * No other serious medical condition * A psychiatric disorder that would prohibit the subject from participating fully. * Peripheral neuropathy \> grade 1 * History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma. * HIV positive patients
References
Publications (0)
Data not yet available