Current Clinical Trials

Unresectable gallbladder cancer is defined by the following TNM classification:

• Any T, N1, M0
• Any T, N0 or N1, M1
• Most T3, N0, M0
• T4, N0, M0

These patients are not curable. Significant symptomatic benefit can often be achieved with relief of biliary obstruction. A few patients have very slow-growing tumors and may live several years.

Standard treatment options:

Palliative treatment options may include the following:

1. The preferred approach to biliary obstruction is percutaneous transhepatic radiologic catheter bypass or endoscopically placed stents.[1]
2. Standard external-beam radiation therapy can, on occasion, alleviate biliary obstruction in some patients and may supplement bypass procedures.
3. Palliative surgery may relieve bile duct obstruction and is warranted when symptoms produced by biliary blockade (pruritus, hepatic dysfunction, and cholangitis) outweigh other symptoms from the cancer.
4. Standard chemotherapy is usually not effective, though occasional patients may be palliated. Clinical trials should be considered as a first option for most patients.[2,3]

Treatment options under clinical evaluation:

• Clinical trials are in progress to improve local control rates by radiation therapy using brachytherapy and/or radiosensitizer drugs or to discover more effective forms of chemotherapy. When possible, patients should be considered for these clinical trials.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with unresectable gallbladder cancer ¹. 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 ².

References

1. 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]
   
   
2. Bartlett DL, Ramanathan RK, Deutsch M: Cancer of the biliary tree. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds.: Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, Pa: Lippincott Williams & Wilkins, 2005, pp 1009-31. 
   
   
3. Hejna M, Pruckmayer M, Raderer M: The role of chemotherapy and radiation in the management of biliary cancer: a review of the literature. Eur J Cancer 34 (7): 977-86, 1998.  [PUBMED Abstract]