Clinical trial · Interventional
Radiation Dose Escalation in Locally Advanced Rectal Cancer
Phase II Study of Neoadjuvant Radiotherapy Dose Escalation in Association With Chemotherapy for the Treatment of Locally Advanced 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)
This is a one arm study where patients with locally advanced rectal cancer will receive neoadjuvant treatment with escalated dose radiotherapy (with 3D conformal radiotherapy, up to 59,4 Gy) and radiosensitizing chemotherapy. Then, patients will operated (total mesorectal excision) after 8 weeks of interval. Primary endpoint will be pCR (pathologic complete response).
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 |
|---|---|---|---|
| Delayed surgery | Procedure | — | UNRESOLVED |
| Dose Escalation Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Locally advanced rectal cancer
- description
- RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV + Chemotherapy with 5-FU Surgery 8 weeks after the neoadjvuant treatment.
- interventionNames
- Radiation: Dose Escalation Radiotherapy
- Procedure: Delayed surgery
Primary outcomes (1)
- measure
- Pathologic complete response
- timeFrame
- Through study completion, an average of 2 years
- description
- Pathologic evaluation of the surgical specimen
Secondary outcomes (2)
- measure
- Disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced rectal cancer, 0-15 cm from anal verge, cT3/4 or cN+ Exclusion Criteria: * Metastatic disease, previous chemotherapy, previous radiotherapy, previous malignant non-skin tumor
References
Publications (0)
Data not yet available