Cancer colorectal stage IV with synchronous non-resectable metastasis. MedDRA version: 16.0 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Injection
INN or Proposed INN: FLOUROURACIL
CAS Number: 51-21-8
Other descriptive name: 5-FLOUROURACIL
Pharmaceutical Form: Powder and solvent for solution for injection
INN or P
Sponsors
Servicio de Cirugía General y Digestiva Hospital Universitario de Bellvitge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Primary adenocarcinoma of the colon or upper rectum. Only include rectal tumors located above 12 cm from the anal margin (the distance from the anal verge will be evaluated by rigid proctoscopy if in doubt). - Radiologically resectable primary tumor (as CT or MRI). or In the case of higher rectum tumor, no infiltration of vascular, nerve or bone. or in cases of colorectal tumor invasion T4 with neighboring organs (abdominal wall, uterus, bladder, small intestine, liver segment, gall bladder, second or fourth portion of the duodenum, pancreas tail or greater curvature of the stomach) measured radical resection. - No urgent or emergent surgery of the primary tumor by an event related to the same. In the case of occlusion and endoluminal stenting with clinical success, the patient may be included in the randomization. - Radiological Confirmation unresectable synchronous metastases, both liver and in other locations. Unresectability criteria will be evaluated by a Committee of Experts on the Functional Unit of Colorectal Cancer of each center or by a multidisciplinary team. - Absence of peritoneal carcinomatosis in the radiological study. - Before completing any study-related procedures listed in Section 6.3, the patient must give informed consent to participate, in writing, signed and dated. - Staging performed in less than 3 weeks prior to randomization. - No contraindications for chemotherapy. - ECOG performance status ? 2. - Patient considered mentally and physically fit to receive chemotherapy and surgical treatment, judging by the multidisciplinary team. - Age ? 18 years. - Not pregnant or nursing. - Negative pregnancy test in patients of childbearing age. - Adequate monitoring potential. 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 56 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 280
Exclusion criteria
Exclusion criteria: - Infiltration of bone structures, vascular or nerve root infiltration of the superior mesenteric artery or the head of the pancreas. - Presence of multiple bone metastatic disease or central nervous system. - Concomitant neoplastic disease in the past 5 years except basal cell carcinoma or squamous skin or carcinoma "in situ" of the cervix. - Medical or psychiatric condition that compromises the patient's informed consent authorization. - Uncontrolled concomitant medical pathology or stable that could compromise the tolerance to chemotherapy. - Patients with malabsorption syndromes or physical loss of the integrity of the upper digestive tract. - Clinically significant cardiac pathology (congestive heart failure, symptomatic coronary artery disease) and myocardial infarction in the last 6 months. - Patients with symptoms or symptoms of peripheral neuropathy. - Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with colorectal cancer with unresectable synchronous metastases. To determine overall survival increases in resection of the primary tumor and subsequent treatment with palliative chemotherapy (experimental group) compared with treatment with palliative chemotherapy exclusive (control group).;Secondary Objective: - To evaluate the postoperative morbidity and mortality in patients treated with resection of the primary tumor. - To evaluate the need for surgery and complications in patients treated with systemic chemotherapy exclusively during the course of the disease. - To identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. - To identify the prognostic factors for overall survival. - To evaluate the costs associated with each treatment group. - To compare the events between experimental and control groups.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Patients will be followed for at least 2 years from randomisation, or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life measured with questionnaires QLQ-C30 and QLQ-CR29 Evaluation of prognostic factors. Costs associated with each treatment. toxicity Complications of primary tumor Complications of surgery Postoperative Mortality adverse Events;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
Spain
Contacts
Public ContactColo-Rectal Unit
Servicio de Cirugía General y Digestiva Hospital Universitario de Bellvitge
Outcome results
None listed