Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421824
• Other study ID #: PM_L_0098
• Secondary ID: EudraCT # : 2005
• Status: Completed
• Phase: Phase 2
• First received: January 11, 2007
• Last updated: January 3, 2011
• Start date: May 2006
• Est. completion date: November 2010

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Drug:
• Oxaliplatin, capecitabine
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
• Oxaliplatin, capecitabine
XELOX-RT x 5 weeks followed by surgery and 4 cycles of adjuvant XELOX with the same scheme as arm A.

Locations

Country	Name	City	State
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		from the signature of Informed Consent up to the end of the study	No
Secondary	Relative dose intensity		from the signature of Informed Consent up to end of the study	No
Secondary	Disease free survival		from the signature of Informed Consent up to end of the study	No
Secondary	Overall survival		from the signature of Informed Consent up to end of the study	No