Status:
COMPLETED
A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
Lead Sponsor:
Fan Ming
Conditions:
Prosthesis Survival
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01918124
Start Date
January 1 2008
End Date
January 1 2014
Last Update
October 12 2018
Active Locations (1)
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1
Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000