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

Fan Ming

Status and phase: Completed; Phase 2

Conditions: Prosthesis Survival

Treatments: Drug: Paclitaxel and Carboplatin; Radiation: radiotherapy; Drug: Cisplatin; Drug: Cisplatin and Doxorubicin and Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01918124

070148-7

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

radiotherapy combined with chemotherapy

Experimental group

Description:

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.

Treatment:

Radiation: radiotherapy

Drug: Paclitaxel and Carboplatin

Drug: Cisplatin

Drug: Cisplatin and Doxorubicin and Cyclophosphamide