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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radiotherapy combined with chemotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Additional surgical staging procedures are permissible but not required.
Risk factors: patients must fit one of the following:
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 serious internal diseases which affect designed treatment
With psychotic disorders
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| Name | Affiliation | Role |
|---|---|---|
| Huaying Wang, Doctor | Shanghai Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26607778 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Cisplatin | Drug | Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy. |
|
| Cisplatin and Doxorubicin and Cyclophosphamide | Drug | 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 | Drug | Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy. |
|
| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D002945 | Cisplatin |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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