INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY
Conditions
Interventions
radiation therapy( External pelvic standard radiation or IMRT )
Cisplatine 40mg/m2(max=70mg)IV over 1-2 hours weekly 6cycles with radiation therapy( External pelvic standard radiation or IMRT )
Sponsors
NRG Oncology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Patients with 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. 2) Patients with the following characteristics ( depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed ) : 2-1) Patients with Positive capillary-lymphovascular space involvement and one of the following : - Deep third penetration - Middle third penetration, clinical tumor >=2cm - Superficial third penetration, clinical tumor >=5cm 2-2) Patients with Negative capillary-lymphatic space involvement : - Middle or deep third penetration, clinical tumor >= 4cm 3) Patients must have adequate : - Hematologic function : ANC>= 1,500/mcl, platelets >= 100,000/mcl - Renal function : creatinine<= ULN or calculated creatinine clearance>=60 mL/min - Hepatic function : bilirubin <= 1.5 x normal, alkaline phosphate and SGOT <= 3 x normal 4) Patients with GOG performance status 0,1,2. 5) Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery. 6) Patients who have met the pre-entry requirements specified in Section 7.0. 7) Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Exclusion criteria
Exclusion criteria: 1) Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins. 2) Patients with septicemia or severe infection. 3) Patients with intestinal obstruction or gastrointestinal bleeding. 4) Patients with postoperative fistula. 5) Patients with cervix cancer who have received any previous radiation or chemotherapy. 6) Patients whose circumstances do not permit completion of the study or the required follow-up. 7) Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc). 8) Patients with GOG Performance Status of 3 or 4. 9) Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, adverse events | — |
Countries
Japan,Asia(except Japan),North America
Contacts
Public ContactTadao Takano, MD.
Tohoku University School of Medicine Department of Gynecology
Outcome results
None listed