rectal cancer MedDRA version: 6.1 Level: PT Classification code 10038038
Conditions
Interventions
Trade Name: ELOXATIN IV 1 FL 100 MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Oxaliplatin
CAS Number: 61825-94-3
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically confirmed primary adenocarcinoma of the rectum. - Tumour within 12 cm of the anal verge by proctoscopic examination or within 10 cm of the anorectal ring by MRI. - Clinical stages UICC 1997 cT3 N0-2. -Resectable disease at the routine examination. - Age 61619; 18 years. - Karnofsky Performance Status 61619;60. -WBC 61619; 4,000 cells/ml, platelets 61619; 100,000 cells/ml. written informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Evidence of metastatic M1 disease. If there were any suspicious findings i.e. liver metastasis, lung nodule, retroperitoneal adenopathy, etc. the patient is to be considered as ineligible, unless malignancy is ruled out by tissue documentation biopsy before trial therapy is started. - Previous chemotherapy, immunotherapy, or radiation therapy to the pelvis. - Multiple primary cancers involving both the colon and rectum that would preclude a patient from being classified as having only rectal cancer. - Incomplete healing from or other surgery. -Active inflammatory bowel disease. - Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. - Cardiovascular disease with a New York Heart Association Functional Status 2. - Absolute neutrophil count ANC 4 x 109/L or platelets 100 x 109/L. - Mesured Creatinine clearance greater than 65ml/min. no drug dose reduction for lower GFR is allowed . - ALT or AST 2.5 times the ULRR -Pregnancy or breastfeeding women of child-bearing potential . - Any evidence of severe or uncontrolled systemic disease e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease . - Any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -evaluation of T pathological major downstaging, considered as the overall rate of any TRG1 or TRG 2 scored patients; -to evaluate the impact on local control of local excision in patients who had a major clinical response, evaluated by EUS/ MRI, yN0 evaluated by multislice CT / MRI, and confirmed by TRG 1-2 score.;Secondary Objective: -tumour downstaging, evaluated by the comparison of clinical staging before combined modality treatment toward pathological staging. - feasibility of a sphincter saving surgical procedure; -evaluation of activity of preoperative treatment clinical response, facultative -post-surgical functional outcome; -evaluation of the local control of the disease; - estimates Kaplan-Meier, product limit method of the disease free survival; - evaluation of adverse events and adverse reactions to treatment, according to both the RTOG and NCI-CTC criteria.;Primary end point(s): evaluation of T pathological major downstaging, considered as the overall rate of any TRG1 or TRG 2 scored patients | — |
Countries
Italy
Outcome results
None listed