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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00421824

Enrollment

108

Registered

2007-01-12

Start date

2006-05-31

Completion date

2010-11-30

Last updated

2011-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

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.

Interventions

DRUGOxaliplatin, 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Response rate	from the signature of Informed Consent up to the end of the study

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026