Current Clinical Trials

Stage I (old stage: Dukes A or Modified Astler-Coller A and B1)

Because of its localized nature, stage I has a high cure rate.

Standard treatment options:

1. Wide surgical resection and anastomosis when an adequate low anterior resection (LAR) can be performed with sufficient distal rectum to allow a conventional anastomosis or coloanal anastomosis.



2. Wide surgical resection with abdominoperineal resection (APR) for lesions too distal to permit low anterior resection (LAR).



3. Local transanal or other resection [1,2] with or without perioperative external beam radiation plus fluorouracil (5-FU). No randomized trials are available to compare local excision with or without postoperative chemoradiation treatments to wide surgical resection (LAR and APR). One prospective multicenter phase II study and several larger retrospective series suggest that well-staged patients with small (<4 centimeters) tumors with good histologic prognostic features (well- to moderately-differentiated adenocarcinomas), mobile, and no lymphatic, venous, or perineural invasion, treated with full-thickness local excision that results in negative margins may have outcomes equivalent to APR or LAR with the selective post-operative use chemoradiation therapy.[3-5] Endoscopic ultrasound studies have been helpful in defining these patients. Patients with tumors that are pathologically T1 may not need postoperative therapy. Patients with tumors that are T2 or greater have lymph node involvement of 20% or more and require additional therapy, such as radiation and chemotherapy, or more standard surgical resection.[6] Patients with poor histologic features should consider LAR or APR and postoperative treatment as dictated by full surgical staging. The selection of patients for local excision may also be improved by newer imaging techniques, such as endorectal magnetic resonance imaging and endorectal ultrasound.



4. Endocavitary, with or without external beam, radiation in selected patients with tumors less than 3 centimeters in size, with well-differentiated tumors, and without deep ulceration, tumor fixation, or palpable lymph nodes.[7-10] Special equipment and experience are required to achieve results equivalent to surgery.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage I rectal cancer. 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.

References

1. Bailey HR, Huval WV, Max E, et al.: Local excision of carcinoma of the rectum for cure. Surgery 111 (5): 555-61, 1992.  [PUBMED Abstract]
   
   
2. Benson R, Wong CS, Cummings BJ, et al.: Local excision and postoperative radiotherapy for distal rectal cancer. Int J Radiat Oncol Biol Phys 50 (5): 1309-16, 2001.  [PUBMED Abstract]
   
   
3. Willett CG, Compton CC, Shellito PC, et al.: Selection factors for local excision or abdominoperineal resection of early stage rectal cancer. Cancer 73 (11): 2716-20, 1994.  [PUBMED Abstract]
   
   
4. Russell AH, Harris J, Rosenberg PJ, et al.: Anal sphincter conservation for patients with adenocarcinoma of the distal rectum: long-term results of radiation therapy oncology group protocol 89-02. Int J Radiat Oncol Biol Phys 46 (2): 313-22, 2000.  [PUBMED Abstract]
   
   
5. Steele GD Jr, Herndon JE, Bleday R, et al.: Sphincter-sparing treatment for distal rectal adenocarcinoma. Ann Surg Oncol 6 (5): 433-41, 1999 Jul-Aug.  [PUBMED Abstract]
   
   
6. Sitzler PJ, Seow-Choen F, Ho YH, et al.: Lymph node involvement and tumor depth in rectal cancers: an analysis of 805 patients. Dis Colon Rectum 40 (12): 1472-6, 1997.  [PUBMED Abstract]
   
   
7. Sischy B, Graney MJ, Hinson EJ: Endocavitary irradiation for adenocarcinoma of the rectum. CA Cancer J Clin 34 (6): 333-9, 1984 Nov-Dec.  [PUBMED Abstract]
   
   
8. Kodner IJ, Gilley MT, Shemesh EI, et al.: Radiation therapy as definitive treatment for selected invasive rectal cancer. Surgery 114 (4): 850-6; discussion 856-7, 1993.  [PUBMED Abstract]
   
   
9. Maingon P, Guerif S, Darsouni R, et al.: Conservative management of rectal adenocarcinoma by radiotherapy. Int J Radiat Oncol Biol Phys 40 (5): 1077-85, 1998.  [PUBMED Abstract]
   
   
10. Aumock A, Birnbaum EH, Fleshman JW, et al.: Treatment of rectal adenocarcinoma with endocavitary and external beam radiotherapy: results for 199 patients with localized tumors. Int J Radiat Oncol Biol Phys 51 (2): 363-70, 2001.  [PUBMED Abstract]
    
    

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