Final results of a phase III clinical trial on adjuvant intraportal infusion with heparin and 5-fluorouracil (5-FU) in resectable colon cancer (EORTC GITCCG 1983-1987)

European Journal of Cancer Part A

Volumn 33, Issue 8, 1997, Pages 1209-1215

  Nitti, D ^a   Wils, J ^b   Sahmoud, T ^c   Curran, D ^c   Couvreur, M L ^c   Lise, M ^a   Rauschecker, H ^g   Guimaraes Dos Santos, J ^d   Stremmel, W ^e   Roelofsen, F ^f  

^a UNIVERSITY OF PADOVA   (Italy)

^b LAURENTIUS HOSPITAL   (Netherlands)

^c EORTC DATA CENTER   (Belgium)

^d PORTUGUESE ONCOLOGY INSTITUTE   (Portugal)

^e EVANGELISCHES KRANKENHAUS   (Germany)

^f Bethesda Krankenhaus   (Germany)

^g NONE

Author keywords

Adjuvant treatment; Colon cancer; Intraportal 5 FU infusion

Indexed keywords

FLUOROURACIL; HEPARIN;

ADULT; AGED; ARTICLE; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; COLON CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; HUMAN CELL; HUMAN TISSUE; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; NAUSEA; PHASE 3 CLINICAL TRIAL; PORTAL VEIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL TIME;

ADULT; AGED; ANTICOAGULANTS; ANTIMETABOLITES, ANTINEOPLASTIC; CHEMOTHERAPY, ADJUVANT; COLONIC NEOPLASMS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG THERAPY, COMBINATION; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HEPARIN; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MIDDLE AGED; PORTAL VEIN; POSTOPERATIVE COMPLICATIONS; SURVIVAL RATE;

EID: 0030851293     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0959-8049(97)00052-X     Document Type: Article

References (23)

1. Fisher ER, Turnbull RB. The cytological demonstration and significance of tumor cells in the mesenteric blood in patients with colorectal cancer. Surg Gynecol Obstet 1955, 100, 102-107.
2. Ariel FM. Intra-arterial chemotherapy for cancer metastatic to the liver. Arch Surg 1965, 91, 851-862.
3. Storer EH, Akin TJ. Chemotherapy of hepatic neoplasm on the umbilical portal vein. Am J Surg 1966, 111, 56-58.
4. Taylor I, Machin D, Mullee M, et al. A randomized controlled trail of adjuvant portal vein cytotoxic perfusion in colorectal cancer. Br J Surg 1985, 72, 359-363.
5. Taylor I, Rowling J, West C. Adjuvant cytotoxic liver perfusion for colorectal cancer. Br J Surg 1979, 66, 833-837.
6. George SL, Desu MM. Planning the size and duration of a clinical trial studying the time to some critical event. J Chron Dis 1974, 27, 15-24.
7. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975, 31, 103-115.
8. Kaplan EL, Meier P. Non parametric estimation from incomplete observations. J Am Stat Assoc 1958, 53, 457-481.
9. Cox DR. Regression models and life-tables. J R Stat Soc B 1972, 34, 187-202.
10. Ryan J, Weiden P, Crowley J, Bloch K. Adjuvant portal vein infusion for colorectal cancer: a 3-arm randomized trial. Proc ASCO 1988, 7, 95 (abstract 361).
11. Fielding LP, Hittinger R, Grace RH, Fry JS. Randomized controlled trial of adjuvant chemotherapy by portal-vein infusion after curative resection for colorectal adenocaracinoma. Lancet 1992, 340, 502-506.
12. Wereldsma JCJ, Bruggink EDM, Meijer WS, et al. Adjuvant portal liver infusion in colorectal cancer with 5-fluorouracil/ heparin versus urokinase versus control. Cancer 1990, 65, 425-432.
13. Wolmark N, Rockette H, Wickerham DL, et al. Adjuvant therapy of Dukes A, B, and C adenocarcinoma of the colon with portal-vein fluorouracil hepatic infusion: preliminary results of National Surgical Adjuvant Breast and Bowel Project protocol C-02. J Clin Oncol 1990, 8, 1466-1475.
14. Heart RW, Moertel CG, Wieand HS, et al. Adjuvant therapy for resectable colorectal carcinoma with fluorouracil administered by portal vein infusion. Arch Surg 1990, 125, 897-901.
15. Swiss Group for Clinical Cancer research (SAKK). Long-term results of single course of adjuvant intraportal chemotherapy for colorectal cancer. Lancet 1995, 345, 349-353.
16. Metzger U, Gross TH, Honneger HP. Adjuvant treatment for colorectal cancer: 'State of the Art' - messages from recent trials. Eur J Surg Oncol 1995, 21, 341-352.
17. Piedbois P Buyse M Gray R Clarke M et al. for the Liver Infusion Meta Analysis Project.. Portal vein infusion is an effective adjuvant treatment for patients with colorectal cancer. Proc ASCO 1995, 14, 192 (abstract 444).
18. George SL. The required sample size and length of a phase III clinical trial. In Buyse M, Staquet M, Sylvester E eds. Cancer Clinical Trials: Methods and Practice. Oxford, Oxford University Press, 1984, 287-310.
19. Sahmoud T, Rougier P, Nitti D, et al. Adjuvant portal vein infusion of 5-FU and heparin (PVI) in colorectal cancer: An EORTC-GIVIO Intergroup phase III trial. Ann Oncol (S5) 1996, 7, 33.
20. Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med 1982, 1, 121-129.
21. Laurie JA, Moertel CG, Fleming TR, et al. Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil. J Clin Oncol 1989, 7, 1447-1456.
22. Moertel CG, Fleming TR, Macdonald JS, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon cancer. N Engl J Med 1990, 322, 352-358.
23. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. Lancet 1995, 345, 939-944.