Clinical trial · Observational
Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
NCT01152164CI-TRIAL-00006589unknownClinicalTrials.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 goal of this study is gathering informations about patients' quality of life after combined modality treatment of rectal cancer to evaluate how combined modality treatment for rectal cancer affects patients' quality of life. The findings of this study may provide us important information that can be used in treatment decision and to develop programs to improve quality of life of patients with 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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- rectal cancer patients
- interventionNames
- Behavioral: questionnaires
Primary outcomes (1)
- measure
- To prospectively evaluate the quality of life of patients one year after rectal cancer resection
- timeFrame
- one year after the operation
Secondary outcomes (2)
- measure
- To prospectively evaluate the quality of life of patients at baseline
- timeFrame
- before treatment (at baseline)
- description
- consecutive patients treated winh capecitabine-based radiochemotherapy
- measure
- To prospectively evaluate the quality of life of patients two years after rectal cancer resection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * histologically verified adenocarcinoma of the rectum, * clinical stage II or III (IUCC TNM classification 2002); * no prior radiotherapy and/or chemotherapy; * World Health Organisation (WHO) performance status \< 2; * age at diagnosis of 18 or older; * and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease) * mentally fit to complete questionnaires Exclusion Criteria: * a history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix rendered the patient ineligible.
References
Publications (6)
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDSprangers MA, te Velde A, Aaronson NK. The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38). European Organization for Research and Treatment of Cancer Study Group on Quality of Life. Eur J Cancer. 1999 Feb;35(2):238-47. doi: 10.1016/s0959-8049(98)00357-8. PMID 10448266
- BACKGROUNDMoriya Y. Function preservation in rectal cancer surgery. Int J Clin Oncol. 2006 Oct;11(5):339-43. doi: 10.1007/s10147-006-0608-z. PMID 17058130
- BACKGROUNDRauch P, Miny J, Conroy T, Neyton L, Guillemin F. Quality of life among disease-free survivors of rectal cancer. J Clin Oncol. 2004 Jan 15;22(2):354-60. doi: 10.1200/JCO.2004.03.137. PMID 14722043
- BACKGROUNDParker PA, Baile WF, de Moor Cd, Cohen L. Psychosocial and demographic predictors of quality of life in a large sample of cancer patients. Psychooncology. 2003 Mar;12(2):183-93. doi: 10.1002/pon.635. PMID 12619150
- BACKGROUNDOsoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139. PMID 9440735