Clinical trial · Interventional
Dose-escalation Trial of Preoperative Radiotherapy and Concurrent Chemotherapy in Locally Advanced Rectal Cancer
Multicenter Dose-escalation Trial of Radiotherapy in Patients With Locally Advanced Rectal Cancer
NCT02964468CI-TRIAL-00039228unknownN/AClinicalTrials.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 aim of this study is to evaluate the increase of radiation dose administered in patients diagnosed with locally advanced rectal cancer in terms of ypRC with tolerable toxicity, using IMRT (concomitant boost technique).
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 |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3DCRT treatment (sequential boost) | Radiation | — | UNRESOLVED |
| Dose Escalation Intensity Modulated Radiotherapy treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment with IMRT Dose Escalation
- description
- Dose Escalation Intensity Modulated Radiotherapy treatment
- interventionNames
- Radiation: Dose Escalation Intensity Modulated Radiotherapy treatment
- type
- ACTIVE_COMPARATOR
- label
- Treatment with 3DCRT
- description
- 3DCRT treatment (sequential boost)
- interventionNames
- Radiation: 3DCRT treatment (sequential boost)
Primary outcomes (2)
- measure
- Pathologic complete response
- timeFrame
- Through study completion, an average of 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically proven diagnosis of adenocarcinoma of the rectum * Clinically determined to be stage T3 or T4,N0-N2, and M0 -staged by MRI or transrectal ultrasound of the rectum * Patients who are medically operable and who have resectable adenocarcinoma of the rectum at least \<11cm from the anal verge * Adequate liver/renal and haematological function. * Eastern Cooperative Oncology Group (ECOG) performance 0-2 * Age ≥ 18 years * Full blood count obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3 * Platelets ≥ 100,000 cells/mm3 * Haemoglobin ≥ 8.0 g/dl * Serum creatinine within normal institutional limits * Bilirubin within normal institutional limits * AST and ALT \< 2.5 x the IULN * Patient must sign study specific informed consent prior to study entry Exclusion Criteria: * Prior systemic chemotherapy for colorectal cancer; note that prior chemotherapy for a different cancer is allowable. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Any evidence of distant metastases (M1) * A synchronous primary colon carcinoma
References
Publications (0)
Data not yet available
No reference posted for this study.