Phase II study of up-front chemotherapy and neo-adjuvant short-course radiotherapy for resectable rectal carcinoma - COLORE

IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO0 sites50 target enrollmentMarch 12, 2013

Overview

No summary available.

Registry

who.int

Start Date

March 12, 2013

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO

•1\.Patients with histologically or cytologically confirmed diagnosis of adenocarcinoma of the mid\-low rectum (within 12 cm from the anal verge)
•2\.Stage: lowT2N0, T2N\+M0, T3\-4 N\-/\+M0 (N\+ \= \= 3 nodes \>0,5 cm diameter or \= 1 nodes \> 1 cm diameter)
•3\.Age \=18 and \= 80 years
•4\.ECOG performance status 0\-1
•5\.Patients must have normal organ and marrow function as defined below:
•a.\- Leukocytes \= 3,000/?L
•b.\- Absolute neutrophil count \= 1,500/?L
•c.\- Platelets \= 100,000/?L
•d.\- Total bilirubin \= 1\.5 X ULN
•e.\- AST (SGOT)/ALT (SGPT) \= 2\.5 X ULN

•1\.Metastatic disease
•2\.Patients who have had any chemotherapy or radiotherapy prior to entering the study
•3\.Acute or sub\-acute gastrointestinal occlusion
•4\.Participation in another clinical trial, with any investigational agent within 30 days prior the study screening
•5\.Other known malignant neoplastic diseases in the patient’s medical history with a disease\-free interval of less than 5 years (except for previously treated basal cell carcinoma, superficial bladder tumor and in situ carcinoma of the uterine cervix)
•6\.History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study
•7\.Uncontrolled concomitant illness, including but not limited to: ongoing or active infections; congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance to study requirements