Clinical trial NCT01918124: A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prosthesis Survival
Keywords: disease free survival, overall survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Disease Free Survival(DFS)
timeFrame: From date of randomization until the date of first documented progression, assedded up to 60 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of randomization until the date of death from any cause, assedded up to 60 months.
Other outcomes:
measure: Number of patients with adverse events and number of patients completed the treatments
timeFrame: up to 5 years
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Shanghai Cancer Center
name: Huaying Wang, Doctor
role: STUDY_CHAIR
References:
citation: Ren Y, Huang X, Shan B, Wu X, Huang X, Shi D, Wang H. Adjuvant concurrent chemoradiation followed by chemotherapy for high-risk endometrial cancer. Gynecol Oncol. 2016 Jan;140(1):58-63. doi: 10.1016/j.ygyno.2015.11.021. Epub 2015 Nov 24.