A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer (EC-0701)

October 10, 2018 updated by: Fan Ming

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: radiotherapy combined with chemotherapy

Arm Label: radiotherapy combined with chemotherapy:

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.

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) 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.
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.
Drug: 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.
Drug: Paclitaxel and Carboplatin
Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Free Survival(DFS)
Time Frame: From date of randomization until the date of first documented progression, assedded up to 60 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From date of randomization until the date of death from any cause, assedded up to 60 months.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events and number of patients completed the treatments
Time Frame: up to 5 years
Number of patients completed the treatment and number of patients with adverse events up to 5 years.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fan Ming

Investigators

  • Study Chair: Huaying Wang, Doctor, Shanghai Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070148-7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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