An Observational Study of Xeloda (Capecitabine) and Oxaliplatin Prior and Concurrent To Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT01339832
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This observational study is a follow-up study of protocol ML18280. Survival data of patients who took part in and concluded study ML18280 will be collected for up to 5 years after LPLV of ML18270.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2015-12-29
• Results First Submitted QC: 2015-12-29
• Results First Posted: 2016-02-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patients who took part in and concluded study ML18280 according to protocol

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Exclusion Criteria

• N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to 5 years	Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause. In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance). PFS time in days was calculated as PFS \[days\]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS \[days\] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS \[months\]= 12 \* PFS \[days\] /365.25

Secondary Outcome Measures

Name	Time	Method
Tumor Recurrence Rate (Local and Distant)	Up to 5 years	Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection. In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence. Participants with local tumor recurrence ('Was it local to the primary tumor?' answered 'yes'.) compared to participants with distant tumor recurrence (specification for other tumor location given).
Compliance to Diagnostic Procedures in Surveillance	Up to 5 years	The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations
Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)	Up to 5 years	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes
Overall Survival	Up to 5 years	Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause. Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages. OS time in days was calculated as OS \[days\] =date of death date of first intake+ 1, for participants who died, OS \[days\]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS \[months\]= 12 \*OS \[days\] /365.25
Type of Adjuvant Chemotherapy	Up to 5 years	The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported
Length of Adjuvant Chemotherapy	Up to 5 years	The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen. Length of adjuvant chemotherapy was calculated as length \[days\] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.
Long Term Side Effects	Up to 5 years	Long term side effects for bowel and urinary function was assessed. Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence. Urinary function was evaluated according to the presence (YES or NO) of incontinence. Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor). In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.