Clinical trial · Observational
Curative Chemoradiation of Low Rectal Cancer
Curative Chemoradiation of Low Rectal Cancer. A Prospective Multicenter Observational Study
- 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)
The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies. Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients with locoregional tumor control with chemoradiation alone two years after end of treatment
- timeFrame
- 2 years after end of treatment
Secondary outcomes (3)
- measure
- Cumulative incidence of local recurrence after surgery
- timeFrame
- Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
- measure
- Rate of distant metastases
- timeFrame
- Every two months the first year, every three months the second year, every six months the third year, and annually the fourth and fifth years
- measure
- Response and tumor control on MRI scans compared to clinical observations, including rectoscopic examination
- timeFrame
- 6 and potentially 12 weeks after end of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically verified adenocarcinoma of the rectum * Planned abdominoperineal resection (APR) or ultralow resection * Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor. * Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope * Performance status 0-2 * Patient acceptance to collection of biopsies and blood samples for translational research * Age ≥ 18 years * Normal function of bone marrow as evaluated by * neutrophils ≥ 1.5 x 10\^9/l * thrombocytes ≥ 100 * Normal function of liver * alanine aminotransferase (ALAT) \< 2.5 x upper limit of normal * bilirubin \< 2.5 x upper limit of normal * Kidney function \- Serum creatinine \< 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) \> 30 ml/min * Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment. * Written and orally informed consent Exclusion Criteria: * Previous surgical treatment of the present cancer, including transanal excision of tumor. * Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri * Distant metastases verified by imaging or biopsy * Previous radiation treatment of the pelvis * Pregnant or breastfeeding women
References
Publications (0)
Data not yet available