A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
This trial is active, not recruiting.
|Treatments||radiotherapy, cisplatin, cisplatin and doxorubicin and cyclophosphamide, paclitaxel and carboplatin|
|Start date||January 2008|
|End date||January 2014|
|Trial size||80 participants|
|Trial identifier||NCT01918124, 070148-7|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Disease Free Survival(DFS)
time frame: From date of randomization until the date of first documented progression, assedded up to 60 months
Overall Survival (OS)
time frame: From date of randomization until the date of death from any cause, assedded up to 60 months.
Female participants from 18 years up to 75 years old.
- 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.
- 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
|Official title||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|
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