Clinical trial · Interventional
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer
NCT00597311CI-TRIAL-00001110unknownPhase 3ClinicalTrials.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)
Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.
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 |
|---|---|---|---|
| Primary Rectal Cancer | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- preoperative short term radiation group 5x5 Gy and surgery after 6 weeks
- interventionNames
- Radiation: radiotherapy
- type
- EXPERIMENTAL
- label
- 2
- description
- preoperative chemoradiotherapy group 50Gy + 5FU/Lv and surgery after 6 weeks.
- interventionNames
- Radiation: radiotherapy
Primary outcomes (2)
- measure
- 5 years overall and disease free survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge * less than 80 years old * no other cancer during 5 years period * compensate cardiovascular, pulmonary, hepatic and renal functions. Exclusion Criteria: * stage I or IV rectal cancer * other cancer in 5 years period * radiotherapy or chemotherapy in anamnesis * not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc. * pregnancy or baby feeding
References
Publications (1)
- DERIVEDLatkauskas T, Pauzas H, Kairevice L, Petrauskas A, Saladzinskas Z, Janciauskiene R, Gudaityte J, Lizdenis P, Svagzdys S, Tamelis A, Pavalkis D. Preoperative conventional chemoradiotherapy versus short-course radiotherapy with delayed surgery for rectal cancer: results of a randomized controlled trial. BMC Cancer. 2016 Dec 1;16(1):927. doi: 10.1186/s12885-016-2959-9. PMID 27903247