Current Clinical Trials

Some patients with stage IIA pancreatic cancer whose tumors are technically unresectable should be considered for participation in clinical trials.[1] These patients may benefit from palliation of biliary obstruction by endoscopic, surgical, or radiological means.[2] Although some data demonstrate a survival advantage associated with combined chemotherapy and radiation therapy for patients with locally advanced unresectable disease,[3-5] patients with unresectable pancreatic cancer should be considered for participation in clinical trials.

Pain associated with unresectable pancreatic cancer may be palliated with radiation therapy, with or without chemotherapy,[3-6] or with chemical splanchnicectomy with 50% alcohol at the time of surgical exploration.[7] Celiac nerve blocks and local neurosurgical procedures to relieve pain can be considered.[8]

Standard treatment options:

1. Pancreatectomy when feasible, with or without adjuvant fluorouracil (5-FU) chemotherapy and radiation therapy.[9-13]



2. Radiation therapy with 5-FU chemotherapy for patients with locally unresectable disease.[3-5]



3. Palliative surgical biliary bypass, percutaneous radiologic biliary stent placement, or endoscopic biliary stent placement.[7,14]

Treatment options under clinical evaluation:

1. For patients with resected tumors, postoperative radiation therapy with other chemotherapeutic agents. In 2002, the Radiation Therapy Oncology Group completed a prospective, multicenter randomized trial (RTOG-9704 ¹) to evaluate whether gemcitabine chemotherapy administered prior to and following radiation with concurrent 5-FU is superior to adjuvant 5-FU for patients with completely resected tumors; preliminary analysis is pending.



2. For patients with resected tumors, postoperative chemotherapy alone. The European Study for Pancreatic Cancer-3 trial is ongoing to evaluate postoperative chemotherapy with either 5-FU/leucovorin or gemcitabine versus no additional treatment.[15]



3. For patients with technically unresectable tumors, biologic agents in combination with radiation and/or chemotherapy (RTOG-PA-0020 ²).



4. For patients with locally unresectable tumors, preoperative radiation therapy with various chemotherapeutic agents and/or radiosensitizers is under clinical evaluation.



5. Intraoperative radiation therapy and/or implantation of radioactive sources is another treatment option.[6,16]

Information about ongoing clinical trials is available from the NCI Web site. ³

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage II pancreatic cancer ⁴. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site ⁵.

References

1. Pingpank JF, Hoffman JP, Ross EA, et al.: Effect of preoperative chemoradiotherapy on surgical margin status of resected adenocarcinoma of the head of the pancreas. J Gastrointest Surg 5 (2): 121-30, 2001 Mar-Apr.  [PUBMED Abstract]
   
   
2. Sohn TA, Lillemoe KD, Cameron JL, et al.: Surgical palliation of unresectable periampullary adenocarcinoma in the 1990s. J Am Coll Surg 188 (6): 658-66; discussion 666-9, 1999.  [PUBMED Abstract]
   
   
3. Moertel CG, Frytak S, Hahn RG, et al.: Therapy of locally unresectable pancreatic carcinoma: a randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil: The Gastrointestinal Tumor Study Group. Cancer 48 (8): 1705-10, 1981.  [PUBMED Abstract]
   
   
4. Whittington R, Solin L, Mohiuddin M, et al.: Multimodality therapy of localized unresectable pancreatic adenocarcinoma. Cancer 54 (9): 1991-8, 1984.  [PUBMED Abstract]
   
   
5. Moertel CG, Childs DS Jr, Reitemeier RJ, et al.: Combined 5-fluorouracil and supervoltage radiation therapy of locally unresectable gastrointestinal cancer. Lancet 2 (7626): 865-7, 1969.  [PUBMED Abstract]
   
   
6. Tepper JE, Noyes D, Krall JM, et al.: Intraoperative radiation therapy of pancreatic carcinoma: a report of RTOG-8505. Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 21 (5): 1145-9, 1991.  [PUBMED Abstract]
   
   
7. van den Bosch RP, van der Schelling GP, Klinkenbijl JH, et al.: Guidelines for the application of surgery and endoprostheses in the palliation of obstructive jaundice in advanced cancer of the pancreas. Ann Surg 219 (1): 18-24, 1994.  [PUBMED Abstract]
   
   
8. Polati E, Finco G, Gottin L, et al.: Prospective randomized double-blind trial of neurolytic coeliac plexus block in patients with pancreatic cancer. Br J Surg 85 (2): 199-201, 1998.  [PUBMED Abstract]
   
   
9. Kalser MH, Ellenberg SS: Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 120 (8): 899-903, 1985.  [PUBMED Abstract]
   
   
10. Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer. Gastrointestinal Tumor Study Group. Cancer 59 (12): 2006-10, 1987.  [PUBMED Abstract]
    
    
11. Klinkenbijl JH, Jeekel J, Sahmoud T, et al.: Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg 230 (6): 776-82; discussion 782-4, 1999.  [PUBMED Abstract]
    
    
12. Neoptolemos JP, Dunn JA, Stocken DD, et al.: Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet 358 (9293): 1576-85, 2001.  [PUBMED Abstract]
    
    
13. Neoptolemos JP, Stocken DD, Friess H, et al.: A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med 350 (12): 1200-10, 2004.  [PUBMED Abstract]
    
    
14. Baron TH: Expandable metal stents for the treatment of cancerous obstruction of the gastrointestinal tract. N Engl J Med 344 (22): 1681-7, 2001.  [PUBMED Abstract]
    
    
15. ESPAC-3(v2) Phase III Adjuvant Trial in Pancreatic Cancer Comparing 5FU and D-L-Folinic Acid vs. Gemcitabine. Leeds, UK: National Cancer Research Network Trials Portfolio, 2004. Available online. ⁶ Last accessed August 28, 2007. 
    
    
16. Reni M, Panucci MG, Ferreri AJ, et al.: Effect on local control and survival of electron beam intraoperative irradiation for resectable pancreatic adenocarcinoma. Int J Radiat Oncol Biol Phys 50 (3): 651-8, 2001.  [PUBMED Abstract]