Clinical trial · Interventional
Studying Biomarkers in Tumor Tissue and Blood Samples From Patients Undergoing Chemotherapy and Radiation Therapy for Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
Colorectal Cancer Stem Cells Marker Expression in Rectal Cancer Patients Undergoing Chemoradiotherapy-A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No surgeon available to perfrom gastroscopy
Summary
Brief summary (as posted)
RATIONALE: Studying samples of tumor tissue and blood 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 predict how patients respond to treatment. PURPOSE: This phase I trial is studying biomarkers in tumor tissue and blood samples from patients undergoing chemotherapy and radiation therapy for stage II or stage III rectal cancer that can be removed by surgery.
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 (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic biopsy | Procedure | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| RNA analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Estimation of stem cell markers with stated precision
- measure
- Correlation of disease-free survival with post-treatment value and change in expression of colorectal cancer stem cell markers after neoadjuvant chemoradiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* Inferior margin within 16 cm of the anal verge on endoscopic exams
* Locally advanced or low lying disease meeting 1 of the following stage criteria:
* Stage II (T2, N0, M0) disease
* Distal tumor (\< 5 cm from anal verge) invades into muscularis propria but not beyond (T2)
* Stage II (T3-4, N0, M0) disease
* Tumor invades through muscularis propria into subserosa or into non-peritonealized pericolic or perirectal tissues (T3) OR tumor directly invades other organs or structures and/or perforates visceral peritoneum (T4)
* Stage III (any T, N1-2, M0) disease
* Tumor has invaded to any depth with involvement of regional lymph nodes (N1-2)
* Resectable disease
* No suspicious metastatic disease (M1)
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Adequate organ function
* No significant co-morbidities that would preclude the use of neoadjuvant chemoradiotherapy, including any of the following:
* Severe heart failure
* Arrhythmia
* Significant liver or kidney dysfunction
* No psychiatric or addictive disorder that would preclude study compliance
* No bleeding diathesis
* No contraindication for sigmoidoscopy
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy or chemotherapy for rectal cancer
* No concurrent warfarin unless appropriate bridging therapy is arranged during biopsy proceduresReferences
Publications (0)
Data not yet available