Randomized multicenter trial in colorectal cancer patients with non-resectable metastasis. Impact of tumor resection versus chemotherapy alone in survival.

• Conditions: Cancer colorectal stage IV with synchronous non-resectable metastasis.; MedDRA version: 16.0Level: PTClassification code 10010035Term: Colorectal cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001688-22-ES
• Lead Sponsor: Servicio de Cirugía General y Digestiva Hospital Universitario de Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 9 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified