eoadjuvant chemoradiation for patients with adenocarcinoma of the stomach. A feasibility study.
- Conditions
- Gastric cancerNeoadjuvant chemotherapyMaagkankerNeoadjuvante chemoradiatie
- Registration Number
- NL-OMON24232
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
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.<br> 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.<br> 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.<br> 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.<br> 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<br> 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<br> 7. Xiong HQ, Gunderson LL, Yao J, Ajani JA. Chemoradiation for resectable gastric cancer. Review. Lancet Oncology 2003;4:498-505.<br> 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<br> 9. Kinoshita T, Maruyama K, Sasako M, et al: Treatment results of gastric cancer patients: Japanese experience. Tokyo, Berlin, Heidelberg, Springer-Verlag, 1993<br> 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<br> 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<br> 12. Cuschieri A: Recent advances in gastrointestinal malignancy. Ann Chir Gynaecol 78:228-237, 1989<br> 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<br> 14. Katai H, Maruyama K, Sasako M, et al: Mode of recurrence after gastric cancer surgery. Dig Surg 11:99-103, 1994<br> 15. Sue-Ling HM, Johnston D, Martin IG, et al: Gastric cancer: a curable disease in Britain. BMJ 307:591-596, 1993<br> 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<br> 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<br> 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 <br> 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<br> 20. Dent DM, Madden MV, Price SK: Randomized comparison of R1 and R2 gastrectomy for gastric carcinoma. Br J Surg 75:110-112, 1988<br> 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<br> 22. Bonenkamp JJ, Sasako M, Hermans J, et al: Extended lymph-node dissection for gastric cancer. N Engl J Med 340:908-914, 1999<br> 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<br> 24. Hundley JC, Shen P, Shiver SA, et al: Lymphatic mapping for gastric adenocarcinoma. Am Surg 68:931-5, 2002<br> 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<br> 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<br> 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<br> 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 <br> 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 <br> 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<br> 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<br> 32. Park SH, Kim DY, Heo JS, et al: Postoperative chemoradiotherapy for gastric cancer. Ann Oncol 14:1373-7, 2003<br> 33 Hazard L. O'Connell J and Scaife C. Role of radiotherapy in gastric adenocarcinoma W.J.Gastroenterology 2006;12:1511-1520<br> 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<br> 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<br> 35. Roth AD, et al Neoadjuvant radiochemotherapy for locally advanced gastric cancer: a phase I¨CII study Ann of Oncol 2003:14;110-115 <br> 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<br> 37. Ajani JA, Ota DM, Jessup JM et al. Resectable gastric cancer an evaluation of preoperative and postoperative chemotherapy. Cancer 1991;68:1501-6.<br> 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<br> 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<br> 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.<br> 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<br> 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 <br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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.<br> 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<br> 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
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);
1. T1N0 tumors and in situ carcinoma (endoscopic ultrasound) are not eligible;
2. Distant metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the possible delay in performing a curative resection due to increased toxicity of more than 10% with a stopping point at a delay in six patients.
- Secondary Outcome Measures
Name Time Method Secondary endpoints are occurrence of downstaging and changes in pathology (pathological responses). <br /><br>Tissue and serum before and after treatment for genomic profiling, kinome profiling (kinase activity) and protein expression will be collected to determine patterns to predict response to therapy.<br><br /><br /><br>1. To determine pathological responses;<br /><br>2. To determine genomic profile to predict response to treatment;<br /><br>3. To determine the number of R0 resections;<br /><br>4. To determine progression free survival;<br /><br>5. To detect risk of tumor recurrence patterns.<br /><br /> <br>Furthermore we will assess quality of life (QOL) before, during and after this combined treatment. <br>