rectal cancer, primary metastasized, stage IV rectumcarcinoom, primair gemetastaseerd, stadium IV
Conditions
Interventions
1. 5 x 5 Gy radiation therapy
2. Capecitabine 2 x 1000 mg/m2, day 1-14
3. Oxaliplatin 130 mg/m2
4. Bevacizumab 7,5 mg/m2
5. Resection of rectum and metastases.
Sponsors
K. Havenga, M.D. Ph.D.
Eligibility
Inclusion criteria
Inclusion criteria: DISEASE CHARACTERISTICS: 1. Histologically verified adenocarcinoma of the rectum; 2. Initial evaluation 4 weeks or less before inclusion. PRIMARY RECTAL TUMOR: 1. Palpable rectal tumor OR; 2. Tumor below the level S1-2 as judged by sagittal CT or MRI slides; 3. R0 resection (circumferential margin > 1 mm) possible at time of presentation OR; 4. Locally advanced primary tumor in which an R0 resection is feasible after 5x5 Gy radiation therapy and a waiting period. This criterium will be judged based on CT scan or MRI of the pelvis. In general, tumors with lymph node metastases in the obturator fossa or above the promontory are not resectable, even after downsizing. METASTATIC DISEASE: 1. Resectable or ablatable liver metastases. This criterium is judged on the following criteria: A. No metastatic disease adjacent to or apparently involving all three major hepatic veins, the portal vein bifurcation or the retro hepatic vena cava; B. No metastatic disease adjacent to or involving the main right or main left portal vein and the main hepatic vein of the opposite lobe; C. No metastatic disease that would require more than a right or left trisegmentectomy; D. No presence of six or more metastatic lesion distributed diffusely in both lobes of the liver; E. No metastatic liver disease that would require a resection that would jeopardize postoperative liver function. 2. Resectable lung metastases. This criterium is judged on the size, number and location of lesions and on the condition and lung capacity of the patient; 3. No metastatic disease in more than two organs, based on CT scan or FDG-PET scan; 4. No peritoneal metastases as demonstrated on CT scan, FDG-PET scan or during laparotomy; 5. No clinical signs of brain metastases. PATIENT CHARACTERISTICS: 1. GENERAL: A. 18 years and above; B. ECOG performance status 0 or 1; C. Ability to withstand major operative procedure; D. Written informed consent obtained prior to any study specific screening procedures; E. Patient must be able to comply with the protocol. 2. HEMATOPOIETIC: A. White blood cell count at least 3000/mm3. B. Platelet count at least 100.000/mm3; C. No bleeding diathesis or coagulopathy. 3. HEPATIC: A. Total bilirubin less than 1.5 x upper limit of normal; B. ASAT/ALAT less than 2,5 times upper limit of normal; C. INR less than 1,5 (for patients receiving coumarin derivates). 4. RENAL: A. Creatinine normal OR; B. Creatinine clearance at least 50 ml/min; C. Negative urine dipstick for protein OR; D. Protein less than 1 g on 24-hour urine collection. 5. CARDIOVASCULAR; A. No history of cerebrovascular attack or transient ischemic attack; B. No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication); C. No unstable angina pectoris; D. No myocardial infarction within the past year; E. No New York Heart Association class II-IV congestive heart failure; F. No serious cardiac arrhythmia requiring medication; G. No peripheral vascular disease ≥ grade II; H. No other clinically significant cardiovascular disease; I. No other unstable or uncompensated cardiac disease. 6. OTHER: A. No unstable or uncompensated respiratory disease; B. No
Exclusion criteria
Exclusion criteria: See inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of complete resection or ablation (R0) of all primary and metastatic tumor. | — |
Secondary
| Measure | Time frame |
|---|---|
| Two-year survival, two-year recurrence rate, and treatment associated toxicity. | — |
Contacts
Public ContactK. Havenga
Department of Surgery University Medical Center Groningen PO. Box 30.001
Outcome results
None listed