Clinical trial · Interventional
Pre-operative 3-DCRT vs IMRT for Locally Advanced Rectal Cancer
Randomised Phase II Study of Pre-operative 3-D Conformal Radiotherapy (3-DCRT) Versus Intensity Modulated Radiotherapy (IMRT) for Locally Advanced Rectal Cancer
NCT02151019CI-TRIAL-00107893TRI-LARCterminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to futility
Summary
Brief summary (as posted)
The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced 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 |
|---|---|---|---|
| Locally Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 50.4 Gy / 28# external beam pelvic radiotherapy delivered using IMRT
- interventionNames
- Radiation: IMRT
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- 50.4 Gy / 28# external beam pelvic radiotherapy delivered using a 3-Dimensional (3-D) planned technique
Primary outcomes (1)
- measure
- Reduction in incidence of grade 2 or higher GI toxicity
- timeFrame
- 10 years
- description
- To determine if there is a reduction in the incidence of grade 2 or higher acute GI toxicity in the IMRT arm, as compared to the Control / 3-D arm, graded by the NCI-CTCAE Version 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing pre-operative pelvic chemo-radiotherapy for histologically confirmed rectal adenocarcinoma, with the following staging: cT3N0-2, cT4N0-2, cT(any)N1-2, cT(any)N(any) CRM at-risk \[AJCC version V\] * Staging / imaging of pelvis with MRI, and CT Thorax/Abdomen * No evidence of metastatic disease * ECOG Performance Status 0 - 2 * Age \> or equal to 18 years * Provision of written informed consent in line with ICH-GCP guidelines Exclusion Criteria: * Previous radiotherapy to the pelvic region * Patients in whom induction chemotherapy has been delivered prior to chemo- radiotherapy * History of inflammatory bowel disease * Previous hip replacement * Previous bowel surgery (excluding procedures/operations which would not result in small bowel adhesions - at the discretion of the Principal Investigator) * Patients with other syndromes/conditions associated with increased radiosensitivity * Any other co-existing malignancies within the past 5 years other than non- melanoma skin cancer * Pregnancy or lactation at the time of proposed randomisation * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
References
Publications (1)
- DERIVEDGeary RL, Gillham C, McVey G, Armstrong J, Cunningham M, Rangaswamy G, Sharma D, Wallace N, Skourou C, Dunne M, Mahon M, Bradshaw S, O'Sullivan L, Marron J, Parker I, Shannon AM, McDermott R, Toomey S, Hennessy BT, O'Neill B. Quality-of-Life Analysis of a Phase II Randomised Controlled Trial Comparing Three-Dimensional Conformal Radiotherapy and Intensity-Modulated Radiotherapy in Locally Advanced Rectal Cancer. Clin Oncol (R Coll Radiol). 2025 Jan;37:103695. doi: 10.1016/j.clon.2024.103695. Epub 2024 Nov 20. PMID 39693793