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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339832
First Posted: April 21, 2011
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Capecitabine and Oxaliplatin Prior and Concurrent to Preoperative Pelvic Radiotherapy in Patients With Locally Advanced Rectal Cancer: A Survival Analysis.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 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:
  • Overall Survival [ Time Frame: 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

  • Tumor Recurrence Rate (Local and Distant) [ Time Frame: 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).

  • Type of Adjuvant Chemotherapy [ Time Frame: Up to 5 years ]
    The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported

  • Length of Adjuvant Chemotherapy [ Time Frame: 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.

  • Compliance to Diagnostic Procedures in Surveillance [ Time Frame: 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

  • Long Term Side Effects [ Time Frame: 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.

  • Incidence of Adverse Event (AE) and Serious Adverse Event (SAE) [ Time Frame: 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


Enrollment: 51
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal cancer patients having taken part in study ML18280
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339832


Locations
Switzerland
Basel, Switzerland, 4031
Chur, Switzerland, 7000
Luzern, Switzerland, 6004
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8063
Sponsors and Collaborators
Hoffmann-La Roche
Sanofi
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01339832     History of Changes
Other Study ID Numbers: ML21875
First Submitted: April 20, 2011
First Posted: April 21, 2011
Results First Submitted: December 29, 2015
Results First Posted: February 4, 2016
Last Update Posted: May 17, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents