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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01918124
Other study ID # 070148-7
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2008
Est. completion date January 2014

Study information

Verified date October 2018
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 with high-risk endometrial cancer.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 2014
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Radiation:
radiotherapy
Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.
Drug:
Cisplatin
Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.
Cisplatin and Doxorubicin and Cyclophosphamide
Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.
Paclitaxel and Carboplatin
Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

Locations

Country Name City State
China Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fan Ming

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of patients with adverse events and number of patients completed the treatments Number of patients completed the treatment and number of patients with adverse events up to 5 years. up to 5 years
Primary Disease Free Survival(DFS) From date of randomization until the date of first documented progression, assessed up to 60 months. From date of randomization until the date of first documented progression, assedded up to 60 months
Secondary Overall Survival (OS) From date of randomization until the date of death from any cause, assessed up to 60 months. From date of randomization until the date of death from any cause, assedded up to 60 months.
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