Clinical trial · Interventional
Capecitabine, Oxaliplatin, Selenomethionine, and Radiation Therapy in Treating Patients Undergoing Surgery For Newly Diagnosed Stage II or III Rectal Adenocarcinoma
A Phase II Study of Capecitabine, Oxaliplatin and Selenomethionine and Radiation Therapy in Patients With Stage II and III Rectal Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to poor/low accrual
Summary
Brief summary (as posted)
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. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together With selenomethionine and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well selenomethionine works when given together with capecitabine, oxaliplatin, and radiation therapy in treating patients undergoing surgery for newly diagnosed 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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pharmacological study | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| selenomethionine | Dietary Supplement | — | UNRESOLVED |
| therapeutic conventional surgery |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine, Oxaliplatin, Selenomethionine, Radiation Therapy
- description
- Oxaliplatin: 50 mg/m2 weekly x 5 Capecitabine 725 mg/m2BID on days of RT Selenomethionine: 4000mcg/m2 PO BID X 7 days prior to RT, then 4000mcg/m2 PO QD from first to last day of RT, including weekends
- interventionNames
- Dietary Supplement: selenomethionine
- Drug: capecitabine
- Drug: oxaliplatin
- Other: laboratory biomarker analysis
- Other: pharmacological study
- Procedure: adjuvant therapy
- Procedure: neoadjuvant therapy
- Procedure: therapeutic conventional surgery
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Complete Pathological Response Rate
- timeFrame
- After completion of capecitabine, oxaliplatin, selenomethionine, and radiation, and before surgery. Assessed endoscopically.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed rectal adenocarcinoma that is involving the distal 12 cm of the rectum (above the anal verge) * Staged within 8 weeks prior to initiation of study by endoscopic ultrasound OR MRI or CT scan if endorectal ultrasound is non-conclusive or non-tolerable * T3-T4 tumor or evidence of lymph node involvement defined by the presence of at least 1 enlarged peri-rectal lymph node * No evidence of distant or known metastases PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% * Life expectancy \> 1 year * Leukocytes ≥ 3,000/µL * Absolute neutrophil count ≥ 1,500/µL * Platelet count ≥ 100,000/µL * Total bilirubin ≤ upper limit of normal (ULN) * AST/ALT ≤ 2.5 times ULN * Creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min * Able to receive oral medication * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent or previous malignancies unless disease free for \> 5 years (excluding nonmelanoma skin cancer) * No neuropathy ≥ grade 2 * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or selenomethionine * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the pelvis * No prior chemotherapy * No other concurrent investigational or anticancer agents or therapies * No concurrent vitamin B6 supplementation (except as part of a standard, multivitamin supplement)
References
Publications (0)
Data not yet available