Brief Summary

Primary objective:

Pathological complete response (ypT0N0) rate Secondary objectives:
Histopathological R0 resection rate
Pathological downstaging (ypT0-T2N0) rate
One month surgical complication rate
Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
Safety
Local and distant recurrence rates
Progression-free survival
Overall survival

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jul 2003

Typical duration for phase_2

Geographic Reach

7 countries

7 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

4.3 years study duration

Study Start

First participant enrolled

July 1, 2003

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed

Last Updated

December 7, 2009

Status Verified

December 1, 2009

Enrollment Period

4.3 years

First QC Date

September 9, 2005

Last Update Submit

December 4, 2009

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

MRI staging and TME surgery
within 4 - 6 weeks after completion XELOX-RT

Secondary Outcomes (1)

Measure safety - NCI-CTC version 2
from baseline to end of study

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: Oxaliplatin, capecitabine, radiotherapy

Interventions

Oxaliplatin, capecitabine, radiotherapyDRUG

* Oxaliplatin 50mg/m² I.V. 2 hours weekly x 5 doses * Capecitabine 825mg/m² P.O. B.I.D. daily x 5 days x 5 weeks * Radiotherapy 45 Gy total (1.8Gy/dose) 25 fractions daily x 5 days x 5 weeks

Single arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

* Histologically proven adenocarcinoma of the rectum (Tumour ≤ 12 cm from the anal verge) * No evidence of distant spread * No prior therapy for chemotherapy or radiation therapy for rectal cancer * Patient considered locally advanced by MRI: * Tumour beyond mesorectal fascia, or * Tumour ≤ 2mm from mesorectal fascia, or * T3 tumour \< 5cm from anal verge * For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception * No peripheral neuropathy \> grade1 * ECOG PS ≤ 2 * ANC \> 1,500 x 10\^9/L * Platelets \> 100,000 x 10\^9/L * Creatinine \< 1.5 x IULN * Bilirubin \< 1.5 IULN * SGPT (ALT) \< 2.5 IULN * No pre-existing condition which would deter chemoradiotherapy * No uncontrolled diarrhoea or fecal incontinence * No significant small bowel (\> 200cc or 6X6X6cm) delineated within the radiation fields * No other serious uncontrolled concomitant illness * Informed consent signed 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 discuss eligibility requirements. They can help determine if this study is right for you.