Clinical trial · Observational
Biomarkers in Patients With Rectal Cancer Undergoing Chemotherapy and Radiation Therapy
A Biologic Study of Global Gene Expression, NF-Kappa B and p53 in Adenocarcinoma of the Rectum.
NCT00280761CI-TRIAL-00060267completedClinicalTrials.gov clinicaltrialsProvenance
- 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: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand how patients respond to treatment. PURPOSE: This clinical trial is studying biomarkers in patients with rectal cancer undergoing chemotherapy and radiation therapy.
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-fluorouracil | Drug | Fluorouracil | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Single Arm Trial
- interventionNames
- Drug: capecitabine
- Drug: 5-fluorouracil
- Procedure: Surgical Resection
- Radiation: Radiation therapy
Primary outcomes (2)
- measure
- Activation of NF-kappa B in response to treatment with external beam radiotherapy
- timeFrame
- 6-8 weeks after chemoradiation
- measure
- Correlation of NF-kappa B pathway activation with therapeutic outcomes
- timeFrame
- 6-8 weeks after chemoradiation
Secondary outcomes (5)
- measure
- Downstream events induced by NF-kappa B activation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Must have rectal or sigmoid-rectal junction adenocarcinoma confirmed by sigmoidoscopy and pathologic diagnosis of biopsy sample * Inferior margin of the tumor less than 15 cm from anal verge by rigid sigmoidoscopy or below the level of S1-2 at surgery * Candidate for chemotherapy and radiotherapy, as defined by any of the following: * Tumor staged as T3 or N1-2 by rectal sonography * Tumor occupying \> 40% of circumference of rectum * Tumor fixed to extra colonic structures as determined by digital rectal examination * Tumor \< 5 cm from sphincter mechanism * Patient has inoperable disease and is being treated for palliation * Pelvic or anastomotic recurrences of previously resected rectal cancer * Planning to undergo chemotherapy and radiotherapy * No sigmoid carcinoma (carcinoma proximal to the pelvic peritoneal reflection) PATIENT CHARACTERISTICS: * Not pregnant PRIOR CONCURRENT THERAPY: * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.