Clinical trial · Observational
Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
A Prospective Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy
NCT00952926CI-TRIAL-00043149completedClinicalTrials.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)
The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.
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
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Frequency of local recurrence
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Frequency of cumulative local recurrence
- timeFrame
- Up to 5 years
- measure
- Frequency of distant metastases verified by planned PET/CT scans
- timeFrame
- Up to 5 years.
- measure
- Overall survival
- timeFrame
- Up to 5 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically verified adenocarcinoma in the rectum * Planned APR or ultra low resection * Primary resectable T2 or T3 tumor * Distance from anus to lower edge of tumor ≤ 6 cm * Suited for curative intended radiation and chemotherapy * Accept taking of biopsy and blood samples for translational research * Age ≥ 18 years * Normal function of bone marrow * leukocytes ≥ 3 x 10\^9/l * thrombocytes ≥ 100 * Normal liver function * ALAT \< 2.5 x upper normal value * bilirubin \< 2.5 x upper normal value * Renal function * Serum creatinin \< 1.5 x upper normal value * Written and orally informed consent Exclusion Criteria: * Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri * Distant metastases * Pregnant or breast feeding patients
References
Publications (1)
- DERIVEDAppelt AL, Ploen J, Harling H, Jensen FS, Jensen LH, Jorgensen JC, Lindebjerg J, Rafaelsen SR, Jakobsen A. High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study. Lancet Oncol. 2015 Aug;16(8):919-27. doi: 10.1016/S1470-2045(15)00120-5. Epub 2015 Jul 5. PMID 26156652