Clinical trial · Interventional
Preoperative Radiotherapy and Local Excision in Rectal Cancer
The Randomised Study of Preoperative Radiotherapy and Local Excision for Radiosensitive Rectal Cancer
- 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)
According to the current opinion, local excision in rectal cancer should be limited to selected T1N0 tumours. The investigators addressed the question whether preoperative radio(chemo)therapy can expand the use of this procedure for more advanced cancers. The rationale of preoperative radiotherapy is eradication of mesorectal subclinical disease. Besides, there is a correlation between radiosensitivity of rectal cancers and low cancer aggressiveness. For this reason, conversion to abdominal surgery is needed in patients with radioresistant tumour. The investigators aim to compare the short-course radiotherapy schedule with the chemoradiation in order to determine an optimal scheme. The study hypothesis is that the chemoradiation assures 25% more patients who do not require conversion to an open surgery. In addition, the aim is to asses safety and efficiency of preoperative radiotherapy and local excision for radiosensitive 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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiochemotherapy | Radiation | — | UNRESOLVED |
| Short course of radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Preoperative radiotherapy with five fractions of 5 Gy during one week and boost 4 Gy after 1 week interval, total dose 29 Gy; after 6 weeks full-thickness local excision
- interventionNames
- Radiation: Short course of radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Radiochemotherapy with 28 fractions of 1,8 Gy plus boost 5,4 Gy in 3 fractions \+ simultaneous bolus 5-Fluorouracil and leucovorin; after 6 weeks full-thickness local excision
- interventionNames
- Radiation: Radiochemotherapy
Primary outcomes (1)
- measure
- The rate of patients with downstaging after radiotherapy to pathological complete response or ypT1 disease with negative margins.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven good or moderately differentiated adenocarcinoma of rectum * Extraperitoneal tumour (\< 3-4 cm; unfavourable cT1 or cT2-3; N0) * No evidence of distant metastases on chest X-ray and abdominal CT or sonography * Signed by patient written informed consent Exclusion Criteria: * Poorly differentiated pathology (G3) * Patients unfit for chemotherapy * No agreement for randomisation
References
Publications (2)
- BACKGROUNDBujko K, Sopylo R, Kepka L. Local excision after radio(chemo)therapy for rectal cancer: is it safe? Clin Oncol (R Coll Radiol). 2007 Nov;19(9):693-700. doi: 10.1016/j.clon.2007.07.014. Epub 2007 Sep 4. PMID 17766096
- BACKGROUNDBujko K, Richter P, Kolodziejczyk M, Nowacki MP, Kulig J, Popiela T, Gach T, Oledzki J, Sopylo R, Meissner W, Wierzbicki R, Polkowski W, Kowalska T, Stryczynska G, Paprota K; Polish Colorectal Study Group. Preoperative radiotherapy and local excision of rectal cancer with immediate radical re-operation for poor responders. Radiother Oncol. 2009 Aug;92(2):195-201. doi: 10.1016/j.radonc.2009.02.013. Epub 2009 Mar 16. PMID 19297050