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

NCT01339832 | Completed Results

• 1 other identifier: ML21875
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 5

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  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

  Up to 5 years

Secondary Outcomes (7)

• Overall Survival

  Up to 5 years

• Tumor Recurrence Rate (Local and Distant)

  Up to 5 years

• Type of Adjuvant Chemotherapy

  Up to 5 years

• Length of Adjuvant Chemotherapy

  Up to 5 years

• Compliance to Diagnostic Procedures in Surveillance

  Up to 5 years

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients having taken part in study ML18280

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Sanofi: collaborator

Study Sites (5)

Unknown Facility

Basel, 4031, Switzerland

Location

Unknown Facility

Chur, 7000, Switzerland

Location

Unknown Facility

Lucerne, 6004, Switzerland

Location

Unknown Facility

Sankt Gallen, 9007, Switzerland

Location

Unknown Facility

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2011
• First Posted: April 21, 2011
• Study Start: August 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 17, 2017
• Results First Posted: February 4, 2016

Record last verified: 2017-04

Locations

CH (5)