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

Prosthesis Survival Clinical Trial

— EC-0701  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918124
• Other study ID #: 070148-7
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Prosthesis Failure
• Prosthesis Survival

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.

External Links

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