NCT00796718

Brief Summary

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

August 25, 2016

Completed
Last Updated

August 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

November 21, 2008

Results QC Date

July 14, 2016

Last Update Submit

July 14, 2016

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Pathological Complete Response

    Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.

    Up to 11 weeks (assessed at the time of post-treatment surgery)

Secondary Outcomes (3)

  • Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)

    Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)

  • Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)

    Up to 15 weeks (assessed 1 month after surgery)

  • Percentage of Participants With Adverse Events

    Up to 15 weeks

Study Arms (1)

Capecitabine

EXPERIMENTAL

Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.

Radiation: Standard radiotherapyDrug: Capecitabine [Xeloda]

Interventions

Standard radiotherapyRADIATION

Administered as prescribed according to normal clinical practice.

Capecitabine
Capecitabine [Xeloda]DRUG

825 milligrams per meter square (mg/m\^2) orally twice daily for 5 weeks.

Also known as: Xeloda®
Capecitabine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-80 years of age;
  • rectal cancer;
  • planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

You may not qualify if:

  • previous radiotherapy or chemotherapy for colorectal cancer;
  • clinically significant cardiovascular disease;
  • significant gastric or small intestine disease;
  • serious uncontrolled active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Banská Bystrica, 975 17, Slovakia

Location

Unknown Facility

Bratislava, 833 10, Slovakia

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800-821-8590

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
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

November 24, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 25, 2016

Results First Posted

August 25, 2016

Record last verified: 2016-07

Locations

SL(2)