This trial is active, not recruiting.

Condition rectal cancer
Treatment questionnaires
Sponsor Institute of Oncology Ljubljana
Start date January 2008
End date September 2012
Trial size 167 participants
Trial identifier NCT01152164, 125/08


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
questionnaires EORTC QLQ C30, EORTC QLQ C38
Quality of life assessment using questionnaires EORTC QLQ C30 and 38 at baseline, one year and two years after the surgery of rectal cancer, treated with preoperative capecitabine based radiochemotherapy

Primary Outcomes

To prospectively evaluate the quality of life of patients one year after rectal cancer resection
time frame: one year after the operation

Secondary Outcomes

To prospectively evaluate the quality of life of patients at baseline
time frame: before treatment (at baseline)
To prospectively evaluate the quality of life of patients two years after rectal cancer resection
time frame: two years after the operation

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Quality of Life in Patients After Combined Modality Treatment of Rectal Cancer
Description Over the last two decades, rectal cancer research has lead to better understanding of disease behaviour, resulting in more efficient treatments and higher prevalence of cancer survivors.Due to aggressive therapy, rectal cancer survivors can exhibit late sequelae of treatment, most common being impaired bowel, voiding, sexual malfunctioning and quality of life impairment. In order to determine the impact of rectal cancer and its treatment on patients' quality of life over time, this study will prospectively follow a cohort of patients at specified intervals evaluating their physical symptoms, physical and social functioning and overall quality of life.Medical and sociodemographic factors that might be predictive will be tested.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Institute of Oncology Ljubljana.