NCT00421824

Brief Summary

Primary:

  • To assess complete pathological response rate of both strategies. Secondary:
  • Safety profile
  • To assess downstaging rate of both strategies.
  • To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
  • To compare time to progression and overall survival of both strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

May 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

January 4, 2011

Status Verified

January 1, 2011

Enrollment Period

4.5 years

First QC Date

January 11, 2007

Last Update Submit

January 3, 2011

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Response rate

    from the signature of Informed Consent up to the end of the study

Secondary Outcomes (3)

  • Relative dose intensity

    from the signature of Informed Consent up to end of the study

  • Disease free survival

    from the signature of Informed Consent up to end of the study

  • Overall survival

    from the signature of Informed Consent up to end of the study

Study Arms (2)

A

EXPERIMENTAL
Drug: Oxaliplatin, capecitabine

B

EXPERIMENTAL
Drug: Oxaliplatin, capecitabine

Interventions

Oxaliplatin, capecitabineDRUG

OXA 130 D1 + Capecitabine 2000 / day D1-D14 for 4 cycles. After 10 weeks of rest, XELOX-RT regimen x 5 weeks followed by surgery

Also known as: Radiotherapy
A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with rectal adenocarcinoma.
  • Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
  • Rectal tumour at distal third, or
  • Tumours spread more than 5 mm in perirectal fat
  • Functional state ECOG ≤ 2.
  • Good hematological, hepatic and renal function

You may not qualify if:

  • Previous pelvis radiotherapy.
  • Previous antitumoural chemotherapy
  • Pregnant or breastfeeding women.
  • Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
  • History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
  • Clinically significant cardiovascular disease
  • Confirmed peripheral neuropathy.
  • Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
  • Blood disorders.
  • Intercurrent non-controlled or severe infections.
  • Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

OxaliplatinCapecitabineRadiotherapy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTherapeutics

Study Officials

  • José Mª Taboada, Dr.

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 12, 2007

Study Start

May 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

January 4, 2011

Record last verified: 2011-01

Locations

ES(1)