A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer

A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer

This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.

Inclusion Criteria:

• Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.

Additional surgical staging procedures are permissible but not required.

• Risk factors: patients must fit one of the following:

  • Pelvic lymph node metastases
  • Paraaortic lymph node metastases
  • Grade 3 with myometrial invasion >50%
  • With stromal invasion of cervix
  • Known extrauterine disease (excluding second primary) confined to the pelvis.
  • High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma,

• No known gross residual disease, or distant metastases.

• Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18~75.

• White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl.

• Acceptable hepatic and renal function: creatinine <=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) <=2*normal.

• No medical contraindications to chemotherapy, or radiation therapy.

• Study-specific signed informed consent.

Exclusion Criteria:

• Prior pelvic radiation therapy.

• Positive peritoneal cytology only for stage IIIa (FIGO 1998).

• With history of other malignancies less than 5 years.

• With gross residual disease, or distant metastases.

• With endometrioid endometrial carcinoma and no risk factors:

  • with myometrial invasion <50%
  • Grade 1~2, with myometrial invasion >50%

• With serious internal diseases which affect designed treatment

• With psychotic disorders