resectable rectal carcinoma MedDRA version: 15.1 Level: LLT Classification code 10038052 Term: Rectal carcinoma System Organ Class: 100000004864
Conditions
Sponsors
IRCCS ISTITUTO SCIENTIFICO ROMAGNOLO PER LO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 f. - Creatinine = 1.5 X ULN 6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter 7. Participant is willing and able to give informed consent for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Step A: The primary objective is to evaluate the safety of the radiotherapy. Step B: The primary objective is to evaluate the proportion of patients with pathological complete remission after combined radio-chemotherapy. ;Secondary Objective: Secondary objectives of step B: • To evaluate the safety of the neo-adjuvant treatment • To determine pathological down-staging • To evaluate the anal sphincter saving surgery rate • To assess the duration of disease free survival and overall survival • To evaluate the correlation between biomarker, pathological response and outcome (Biological Auxiliary Study) ;Primary end point(s): Step A: The primary endpoint is the safety of radiotherapy treatment. Step B: The primary endpoint is the proportion of patients with complete pathological remission at the end of the new radio-chemotherapeutic treatment. ;Timepoint(s) of evaluation of this end point: about 36 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objectives: • To evaluate the safety of the neo-adjuvant treatment • To determine pathological down-staging • To evaluate the rate of R0 resection • To evaluate the sphincter saving resection rate • To evaluate median disease free survival and overall survival • To evaluate the correlation between biomarker, pathological response and outcome (auxiliary\subsidiary Biological Study) This study is planned to perform ancillary analysis as well as correlation between the tumor biological features and clinical response. ;Timepoint(s) of evaluation of this end point: about 36 months. | — |
Countries
Italy
Contacts
Public ContactDATA MANAGER
IRCCS IRST
Outcome results
None listed