跳至主要内容
临床试验/NL-OMON24232
NL-OMON24232已完成不适用

eoadjuvant chemoradiation for patients with adenocarcinoma of the stomach. A feasibility study.

niversity Medical Center Groningen0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14

研究概览

简要总结

  1. Devesa SS, Blot WJ, Fraumeni JF, Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer 1998;83(10):2049-53.
    2. van der Sanden GA, Coebergh JW, Schouten LJ, Visser O, van Leeuwen FE. Cancer incidence in The Netherlands in 1989 and 1990: first results of the nationwide Netherlands cancer registry. Coordinating Committee for Regional Cancer Registries. Eur J Cancer 1995;31A(11):1822-9.
    3. Pisani P, Parkin DM, Bray F, Ferlay J. Estimates of the worldwide mortality from 25 cancers in 1990. Int J Cancer 1999;83(1):18-29.
    4. Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer 2001;37 Suppl 8:S4-66.
    5. Gunderson LL, Sosin H. Adenocarcinoma of the stomach: areas of failure in a re-operation series (second or symptomatic look) clinicopathologic correlation and implications for adjuvant therapy. Int J Radiat Oncol Biol Phys 1982:8:1-11
    6. Landry J, Tepper JE, Wood WC etal: Patterns of failure following curative resection of gastric carcinoma. Int J Radiat Oncol Biol Phys 1990:19:1357-62
    7. Xiong HQ, Gunderson LL, Yao J, Ajani JA. Chemoradiation for resectable gastric cancer. Review. Lancet Oncology 2003;4:498-505.
    8. Akoh JA, Macintyre IMC: Improving survival in gastric cancer: review of 5-year survival rates in English language publications from 1970. Br J Surg 79:293-299, 1992
    9. Kinoshita T, Maruyama K, Sasako M, et al: Treatment results of gastric cancer patients: Japanese experience. Tokyo, Berlin, Heidelberg, Springer-Verlag, 1993
    10. Maruyama K, Gunven P, Okabayashi K, et al: Lymph node metastases of gastric cancer. General pattern in 1931 patients. Ann Surg 210:596-602, 1989
    11. Maruyama K, Gunven P, Okabayashi K, et al: Lymph node metastases of gastric cancer. General pattern in 1931 patients. Ann Surg 210:596-602, 1989
    12. Cuschieri A: Recent advances in gastrointestinal malignancy. Ann Chir Gynaecol 78:228-237, 1989
    13. Bonenkamp JJ, van de Velde CJH, Kampschöer GHM, et al: Comparison of factors influencing the prognosis of Japanese, German, and Dutch Gastric cancer patients. World J Surg 17:410-415, 1993
    14. Katai H, Maruyama K, Sasako M, et al: Mode of recurrence after gastric cancer surgery. Dig Surg 11:99-103, 1994
    15. Sue-Ling HM, Johnston D, Martin IG, et al: Gastric cancer: a curable disease in Britain. BMJ 307:591-596, 1993
    16. Hartgrink HH, van der Velde CJ, Putten H et al. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol 2004;22:2069-77
    17. Nashimoto A, Nakajima T, Furukawa H, et al: Randomised trial of adjuvant chemotherapy with mitomycin, fluorouracil, and cytosine arabinoside followed by oral fluorouracil in serosa-negative gastric cancer: Japan clinical oncology group 9206-1. J Clin Oncol 21:2282-2287, 2003
    18. Siewert JR, Böttcher K, Roder JD, et al: Prognostic relevance of systhemic lymph node dissection in gastric carcinoma. Br J Surg 80:1015-1018, 1993
    19. Wanebo HJ, Kennedy BJ, Winchester DP, et al: Gastric carcinoma: does lymph node dissection alter survival? J Am Coll Surg 183:616-624, 1996
    20. Dent DM, Madden MV, Price SK: Randomized comparison of R1 and R2 gastrectomy for gastric carcinoma. Br J Surg 75:110-112, 1988
    21. Robertson CS, Chung SCS, Woods SDS, et al: A prospective randomized trial comparing R1 subtotal gastrectomy with R3 total gastrectomy for antral cancer. Ann Surg 220:176-182, 1994
    22. Bonenkamp JJ, Sasako M, Hermans J, et al: Extended lymph-node dissection for gastric cancer. N Engl J Med 340:908-914, 1999
    23. Cuschieri A, Weeden S, Fielding J, et al: Patient survival after D1 and D2 resections for gastric cancer: long-term results of the MRC randomized surgical trial. Br J Cancer 79:1522-1530, 1999
    24. Hundley JC, Shen P, Shiver SA, et al: Lymphatic mapping for gastric adenocarcinoma. Am Surg 68:931-5, 2002
    25. Birkmeyer JD, Stukel TA, Siewers AE, et al: Surgeon volume and operative mortality in the United States. N Engl J Med 249:2117-27, 2003
    26. MacDonald JS, Smalley SR, Benedetti J, et al: Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 345:725-730, 2001
    27. Hallissey MT, Dunn JA, Ward LC et al. The second British Stomach Cancer Group trial of adjuvant radiotherapy or chemotherapy in resectable gastric cancer: five-year follow-up. Lancet 343:1309-1312;1994
    28. Macdonald JS, Fleming TR, Peterson RF, Berenberg JL, McClure S, Chapman RA, Eyre HJ, Solanki D, Cruz AB Jr, Gagliano R. Adjuvant chemotherapy with 5-FU, adriamycin, and mitomycin-C (FAM) versus surgery alone for patients with locally advanced gastric adenocarcinoma: A Southwest Oncology Group study. Ann Surg Oncol 1995; 2: 488-494
    29. Earle CC, Maroun JA. Adjuvant chemotherapy after curative resection for gastric cancer in non-Asian patients: revisiting a meta-analysis of randomised trials. Eur J Cancer 1999; 35: 1059-1064
    30. Allum W, Cunningham D, Weeden S, et al: Peri-operative chemotherapy in operable gastric and lower oesophageal cancer: randomised controlled trial (the MAGIC Trial). Proc Am Soc Clin Oncol 22:A998, 2003
    31. Cunnigham D, Allum WH, Stenning SP et al. Perioperative chemotherapy in operable gastric cancer and lower oesophageal cancer: final results of a randomised controlled trial (MAGIC trial, ISRCTN 93793971) Proc. Am Soc Clin Oncol 2005
    32. Park SH, Kim DY, Heo JS, et al: Postoperative chemoradiotherapy for gastric cancer. Ann Oncol 14:1373-7, 2003
    33 Hazard L. O'Connell J and Scaife C. Role of radiotherapy in gastric adenocarcinoma W.J.Gastroenterology 2006;12:1511-1520
    33. Smalley SR, Gunderson L, Tepper J et al Gastric surgical adjuvant radiotherapy consensus report: rationale and treatment implementation. Int Radiat Oncol Biol Phys 2002: 52:283-293
    34. Hartgrink HH, van de Velde CJH, Putter H, et al: Neo-adjuvant chemotherapy for operable gastric cancer; long-term results of the Dutch randomised FAMTX trial. Eur J Surg Oncol. 30:643-9, 2004
    35. Roth AD, et al Neoadjuvant radiochemotherapy for locally advanced gastric cancer: a phase I¨CII study Ann of Oncol 2003:14;110-115
    36. Frei E, Miller D, Clark JR et al. Clinical and scientific considerations on preoperative (neoadjuvant) chemotherapy. Rec Res Cancer Res 1986;103:1-5
    37. Ajani JA, Ota DM, Jessup JM et al. Resectable gastric cancer an evaluation of preoperative and postoperative chemotherapy. Cancer 1991;68:1501-6.
    38. Ajani JA, Mayer RJ, Ota DM et al. Preoperative and postoperative chemotherapy for potentially resectable gastric carcinoma. J Natl Cancer Inst 1993;85:1839-44
    39. Ajani JA, Mansfield PF, Ota DM Potentially resectable gastric carcinoma; current approaches to staging and preoperative therapy. World J Surg 1995;19:216-20
    40. Lowy AM, Mansfield PF, Leach SD et al. Response to neoadjuvant chemotherapy best predicts survival after curative resection of gastric cancer Ann Surg 1999;229:303-8.
    41. Safran H, King T, Choy H et al. Paclitaxel and concurrent radiation for locally advanced pancreatic and gastric cancer: a phase I study. J Clin oncol 1997;15:901-7
    42. Safran H, Wanebo HJ, Hesketh PJ et al. Paclitaxel and concurrent radiation for gastric cancer. Int J Radiation Oncol Bio Phys 2000:46:889-94
    43. Choy H, Rodriguez FF, Koester S, Hilsenbeck S, Von Hoff DD. Investigation of taxol as a potential radiation sensitizer. Cancer 1993;71(11):3774-8.
    44. Tishler RB, Schiff PB, Geard CR, Hall EJ. Taxol: a novel radiation sensitizer. Int J Radiat Oncol Biol Phys 1992;22(3):613-7.
    45. Leonard CE, Chan DC, Chou TC, Kumar R, Bunn PA. Paclitaxel enhances in vitro radiosensitivity of squamous carcinoma cell lines of the head and neck. Cancer Res 1996;56(22):5198-204.
    46. Gianni L, Kearns CM, Giani A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 1995;13(1):180-90.
    47. Choy H, Akerley W, Safran H, et al. Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J Clin Oncol 1998;16(10):3316-22.
    48. Choy H, Devore RF, 3rd, Hande KR, et al. A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). Int J Radiat Oncol Biol Phys 2000;47(4):931-7.
    49. Lau D, Leigh B, Gandara D, et al. Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: a California Cancer Consortium phase II trial. J Clin Oncol 2001;19(2):442-7.
    50. Gianni L, Kearns CM, Giani A, et al. Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans. J Clin Oncol 1995;13(1):180-90.
    51. Choy H, Akerley W, Safran H, et al. Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J Clin Oncol 1998;16(10):3316-22.
    52. Choy H, Devore RF, 3rd, Hande KR, et al. A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). Int J Radiat Oncol Biol Phys 2000;47(4):931-7.
    53. Lau D, Leigh B, Gandara D, et al. Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: a California Cancer Consortium phase II trial. J Clin Oncol 2001;19(2):442-7.
    54. Tsai JY, Iannitti D, Berkenblit A, et al. Phase I study of docetaxel, capecitabine, and carbolatin in metastatic esophagogastric cancer. Am J Clin Oncol 2005;28:329-33.
    55. Huang S and Harari PM. Modulation of Radiation receptor blockade in sqaumous cell carcinoma; inhibition of damage repair cell cycle kinetics and tumorangiogenesis Clin Cancer Research 2000;6:2166
    56. Bonner JA,Harari PM, Giralt J et al: Radiotherapy plus Cetuximab for squamous cell carcinoma of the Head and Neck. N Engl J Med 2006;354:567-578

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Histologically proven and documented adenocarcinoma of the stomach;
  • 2. Surgical resectable gastric cancer stage IB-IVA: T1N1; T2-4, N0-1, M0 (see appendix), as determined by Endoscopic Ultra Sound (EUS), Computed Tomography (CT);

排除标准

  • 1. T1N0 tumors and in situ carcinoma (endoscopic ultrasound) are not eligible;
  • 2. Distant metastases;

研究者

相似试验