Clinical trial · Observational
Functional Outcome of Organ Preservation After Neo-adjuvant Chemo Radiation for Rectal Cancer
Follow up and Functional Outcome of Organ Saving Treatment in Patients With Good Response to Neo-adjuvant (Chemo)Radiation for Rectal Cancer
NCT02278653CI-TRIAL-00040666unknownClinicalTrials.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 primary objective is to describe the functional outcome of patients that choose for organ saving 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 Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Manometry | Other | — | UNRESOLVED |
| Questionnaires for the evaluation of Quality of Life | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- The population will consist of patients, aged 18 years or older, with locally advanced rectal cancer who after chemoradiation have a clinical complete response (ycT0N0) or very good response (ycT1-2N0).
- interventionNames
- Other: Questionnaires for the evaluation of Quality of Life
- Other: Manometry
Primary outcomes (1)
- measure
- Functional outcome
- timeFrame
- 5 years
- description
- Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature. Functional outcome will be evaluated with the following questionnaires: 1. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score 2. Short Form (36) health survey 3. EORTC CR38 4. Vaizey score 5. Low Anterior Resection Syndrome (LARS) score 6. International Index of Erectile Function for men 7. International Prostate Symptom Score for men 8. Female Sexual Function Index for women Functional outcome will be measured by manometric measurements: 1. mean basal pressure (mmH2O) 2. maximum squeeze pressure (mmH2O) 3. first sensation (mL) 4. first urge to defecate (mL) 5. maximum tolerable volume (mL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years old * Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response : * Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI) * Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor * Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient * Choosing for the organ-saving treatment option (wait\&see policy or TEM) * Informed consent Exclusion Criteria: * Unable to understand or read Dutch * Unwilling to comply to the questionnaires or manometric measurement.
References
Publications (10)
- BACKGROUNDMaas M, Beets-Tan RG, Lambregts DM, Lammering G, Nelemans PJ, Engelen SM, van Dam RM, Jansen RL, Sosef M, Leijtens JW, Hulsewe KW, Buijsen J, Beets GL. Wait-and-see policy for clinical complete responders after chemoradiation for rectal cancer. J Clin Oncol. 2011 Dec 10;29(35):4633-40. doi: 10.1200/JCO.2011.37.7176. Epub 2011 Nov 7. PMID 22067400
- BACKGROUNDMaas M, Nelemans PJ, Valentini V, Das P, Rodel C, Kuo LJ, Calvo FA, Garcia-Aguilar J, Glynne-Jones R, Haustermans K, Mohiuddin M, Pucciarelli S, Small W Jr, Suarez J, Theodoropoulos G, Biondo S, Beets-Tan RG, Beets GL. Long-term outcome in patients with a pathological complete response after chemoradiation for rectal cancer: a pooled analysis of individual patient data. Lancet Oncol. 2010 Sep;11(9):835-44. doi: 10.1016/S1470-2045(10)70172-8. Epub 2010 Aug 6. PMID 20692872
- BACKGROUNDHabr-Gama A, Perez RO, Proscurshim I, Campos FG, Nadalin W, Kiss D, Gama-Rodrigues J. Patterns of failure and survival for nonoperative treatment of stage c0 distal rectal cancer following neoadjuvant chemoradiation therapy. J Gastrointest Surg. 2006 Dec;10(10):1319-28; discussion 1328-9. doi: 10.1016/j.gassur.2006.09.005. PMID 17175450
- BACKGROUNDLambregts DM, Beets GL, Maas M, Kessels AG, Bakers FC, Cappendijk VC, Engelen SM, Lahaye MJ, de Bruine AP, Lammering G, Leiner T, Verwoerd JL, Wildberger JE, Beets-Tan RG. Accuracy of gadofosveset-enhanced MRI for nodal staging and restaging in rectal cancer. Ann Surg. 2011 Mar;253(3):539-45. doi: 10.1097/SLA.0b013e31820b01f1. PMID 21239980
- BACKGROUNDLambregts DM, Vandecaveye V, Barbaro B, Bakers FC, Lambrecht M, Maas M, Haustermans K, Valentini V, Beets GL, Beets-Tan RG. Diffusion-weighted MRI for selection of complete responders after chemoradiation for locally advanced rectal cancer: a multicenter study. Ann Surg Oncol. 2011 Aug;18(8):2224-31. doi: 10.1245/s10434-011-1607-5. Epub 2011 Feb 23. PMID 21347783
- BACKGROUNDCurvo-Semedo L, Lambregts DM, Maas M, Thywissen T, Mehsen RT, Lammering G, Beets GL, Caseiro-Alves F, Beets-Tan RG. Rectal cancer: assessment of complete response to preoperative combined radiation therapy with chemotherapy--conventional MR volumetry versus diffusion-weighted MR imaging. Radiology. 2011 Sep;260(3):734-43. doi: 10.1148/radiol.11102467. Epub 2011 Jun 14.