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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fan Ming, Fudan University
ClinicalTrials.gov Identifier:
NCT01918124
First received: July 29, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Prosthesis Survival
Radiation: radiotherapy
Drug: Cisplatin
Drug: Cisplatin and Doxorubicin and Cyclophosphamide
Drug: Paclitaxel and Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Disease Free Survival(DFS) [ Time Frame: From date of randomization until the date of first documented progression, assedded up to 60 months ] [ Designated as safety issue: No ]
    From date of randomization until the date of first documented progression, assessed up to 60 months.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, assedded up to 60 months. ] [ Designated as safety issue: No ]
    From date of randomization until the date of death from any cause, assessed up to 60 months.


Other Outcome Measures:
  • Number of patients with adverse events and number of patients completed the treatments [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    Number of patients completed the treatment and number of patients with adverse events up to 5 years.


Estimated Enrollment: 80
Study Start Date: January 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918124

Locations
China, Shanghai
Shanghai Cancer Center
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Fan Ming
Investigators
Study Chair: Huaying Wang, Doctor Shanghai Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fan Ming, Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT01918124     History of Changes
Other Study ID Numbers: 070148-7
Study First Received: July 29, 2013
Last Updated: August 6, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
disease free survival, overall survival

Additional relevant MeSH terms:
Carboplatin
Cisplatin
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014