Clinical trial · Interventional
Resource-Sparing Curative Treatment for Rectal Cancer
NCT01459328CI-TRIAL-00005683unknownPhase 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)
This is a prospective, multicentre, randomized clinical trial comparing two different neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced adenocarcinoma of the rectum. This trial may establish the investigational therapy to be superior to, or at least not inferior to conventional treatment.
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 Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Conventional Long Course Chemo-Radiation
- description
- Conventional long course chemo-radiation
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Arm B: Short Course Radiation Followed by Chemotherapy
- description
- Experimental short course radiation followed by chemotherapy.
- interventionNames
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From commencement of radiation (day 1) to death or last follow-up up to 5 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Clinical (i.e. surgical determination) and/or diagnostic image findings consistent with c/uT4 or CRM+ (note that CRM+ must be established by MRI), primary rectal Adenocarcinoma (i.e. histology consistent with origin from rectal mucosa); these constitute LARC for the purpose of this protocol * Treatment will be directed at the primary cancer, being clinically appropriate and given with an initial intent to cure the patient (this includes accepting up front that radiation and surgery are feasible; for surgery, this means that the patient has been determined fit for major surgery by an anaesthesiologist prior to the request for randomization) * Performance status is sufficient to undertake the treatment in either arm (KPS\>50%) * Patient is accessible for required follow-up and data collection * Radiation oncologist expects survival to exceed 6 months from date of diagnosis * Patient provides informed consent Exclusion Criteria: * Recurrent rectal cancer * Primary wholly in the sigmoid colon * Considered to be arising in the anal canal * Metastatic disease beyond the pelvis (by clinical assessment and/or diagnostic imaging) * Contraindications to protocol RT or to protocol chemotherapy, such as one or more of the following: * any prior RT to the pelvis; a solitary pelvic kidney within the intended radiation volume * consideration by the most responsible radiation oncologist that the treatment volume is too large, or the amount of small bowel or other critical organs within the treatment volume is too much for safe treatment * significantly abnormal laboratory tests such as impaired renal/liver function * a haemoglobin that is \< 8.0 (or 80, SI) and the patient is not transfused to exceed 8.0 (or 80, SI) * on-going medications that are not compatible with protocol neo-adjuvant chemotherapy as described in this protocol * Significant development issues (such as with age \< 18 yr) * Co-morbidity * Psychiatric diagnosis * Physical impairment * Pregnancy or continuing breast-feeding, that precludes administration of protocol treatments, or that precludes data collection (such as likely to preclude follow-up visits or completing questionnaires)
References
Publications (4)
- BACKGROUNDBosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. doi: 10.1056/NEJMoa060829. PMID 16971718
- BACKGROUNDKapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580. PMID 11547717
- BACKGROUNDRadu C, Berglund A, Pahlman L, Glimelius B. Short-course preoperative radiotherapy with delayed surgery in rectal cancer - a retrospective study. Radiother Oncol. 2008 Jun;87(3):343-9. doi: 10.1016/j.radonc.2007.11.025. Epub 2008 Feb 21. PMID 18093674
- BACKGROUNDBraendengen M, Tveit KM, Berglund A, Birkemeyer E, Frykholm G, Pahlman L, Wiig JN, Bystrom P, Bujko K, Glimelius B. Randomized phase III study comparing preoperative radiotherapy with chemoradiotherapy in nonresectable rectal cancer. J Clin Oncol. 2008 Aug 1;26(22):3687-94. doi: 10.1200/JCO.2007.15.3858. PMID 18669453