Current Clinical Trials

Equivalent treatment options:

1. Total hysterectomy:[1] If the depth of invasion is less than 3 mm proven by cone biopsy with clear margins [2] and no vascular or lymphatic channel invasion is noted, the frequency of lymph node involvement is sufficiently low that lymph node dissection is not required. Oophorectomy is optional and should be deferred for younger women.



2. Conization: If the depth of invasion is less than 3 mm, no vascular or lymphatic channel invasion is noted, and the margins of the cone are negative, conization alone may be appropriate in patients wishing to preserve fertility.[1]



3. Radical hysterectomy: For patients with tumor invasion between 3 mm and 5 mm, radical hysterectomy with pelvic node dissection has been recommended because of a reported risk of lymph node metastasis of as much as 10%.[2] However, a study suggests that the rate of lymph node involvement in this group of patients may be much lower and questions whether conservative therapy might be adequate for patients believed to have no residual disease following conization.[3] Radical hysterectomy with node dissection may also be considered for patients where the depth of tumor invasion was uncertain because of invasive tumor at the cone margins.



4. Intracavitary radiation therapy alone: If the depth of invasion is less than 3 mm and no capillary lymphatic space invasion is noted, the frequency of lymph node involvement is sufficiently low that external-beam radiation therapy is not required. One or two insertions with tandem and ovoids for 6,500 mg to 8,000 mg hours (100 Gy–125 Gy vaginal surface dose) are recommended.[4] Radiation therapy should be reserved for women who are not surgical candidates.

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with stage IA cervical 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. Sevin BU, Nadji M, Averette HE, et al.: Microinvasive carcinoma of the cervix. Cancer 70 (8): 2121-8, 1992.  [PUBMED Abstract]
   
   
2. Jones WB, Mercer GO, Lewis JL Jr, et al.: Early invasive carcinoma of the cervix. Gynecol Oncol 51 (1): 26-32, 1993.  [PUBMED Abstract]
   
   
3. Creasman WT, Zaino RJ, Major FJ, et al.: Early invasive carcinoma of the cervix (3 to 5 mm invasion): risk factors and prognosis. A Gynecologic Oncology Group study. Am J Obstet Gynecol 178 (1 Pt 1): 62-5, 1998.  [PUBMED Abstract]
   
   
4. Grigsby PW, Perez CA: Radiotherapy alone for medically inoperable carcinoma of the cervix: stage IA and carcinoma in situ. Int J Radiat Oncol Biol Phys 21 (2): 375-8, 1991.  [PUBMED Abstract]
   
   

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