NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer

NCT02694718

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Rectal Cancer

Interventions: Capecitabine, Oxaliplatin

Countries: Switzerland

The purpose of this study is to determine the pathological complete tumor response rate.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
* Eastern Cooperative Oncology Group performance status 0-2
* Adequate values of laboratory parameters

Exclusion Criteria:

* Evidence of distant metastases
* Previous Chemotherapy or immunotherapy for colorectal cancer
* Previous radiotherapy to the pelvis
* Pre-existing condition which would deter radiotherapy
* Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
* Clinically significant cardiac disease or myocardial infarction within the last 12 months
* Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
* Organ allografts
* Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
* Dihydropyrimidine dehydrogenase (DPD) deficiency
* History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake

Locations (6)

Basel, Switzerland
Chur, Switzerland
Lucerne, Switzerland
Sankt Gallen, Switzerland
Zurich, Switzerland
Zurich, Switzerland