Randomized Phase III Clinical Trial of Adjuvant Radiation versus Chemoradiation in Intermediate Risk, State I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy.

This randomized phase III trial studies radiation therapy with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.

Inclusion Criteria:

* Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed):
- Positive capillary-lymphovascular space involvement and one of the following:
+ Deep third penetration
+ Middle third penetration, clinical tumor ≥ 2 cm
+ Superficial third penetration, clinical tumor ≥ 5 cm
- Negative capillary-lymphatic space involvement
+ Middle or deep third penetration, clinical tumor ≥ 4 cm

Exclusion Criteria:

* Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
* Patients with septicemia or severe infection
* Patients with intestinal obstruction or gastrointestinal bleeding
* Patients with postoperative fistula
* Patients with cervix cancer who have received any previous radiation or chemotherapy
Phase III
Benjamin Bridges , M.D.
GOG (Gynecologic Oncology Group)
Brenda Fisher

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Montana, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.