Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
キーワード
概要
説明
Overall objective For cervical cancer patients with confirmed lymph node metastasis by intraoperative frozen pathology, the overall treatment effect of radical hysterectomy and selective enlarged lymph node dissection is not inferior to systematic pelvic lymphadenectomy and can reduce postoperative lower limb lymphedema incidence and severity.
1. The purpose of this study
1. to assess whether the progression free survival of patients with selective enlarged pelvic lymph node resection is better than patients with systematic pelvic lymph node dissection.
2. to evaluate differences of the incidence and severity of lymphedema between the two group patients using Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology.
2. Preoperative evaluation LEEP, conization or biopsy Vagino-recto-abdominal examination + Vaginal / vaginal colposcopy examination History of Medical, surgical and childbearing Complications Physical condition Height and weight History of smoking Pregnancy test Chest X-ray or chest CT or general PET/CT Abdominal CT or general PET/CT Pelvic MRI/CT or general PET/CT
3.Protocol Patients with stage IB-IIa cervical cancer were randomly divided into two groups(Control group and Experimental group).Frozen pathological examination will be performed during the operation, and patients with positive lymph node metastasis will undergo radical hysterectomy and systematic pelvic lymphadenectomy or radical hysterectomy and selective enlarged lymph node dissection according to the patient's group.
4. Postoperative adjuvant therapy All patients with pelvic lymph node metastasis are required to receive DDP based concurrent chemoradiotherapy.
5.Efficacy evaluation Overall survival (OS): The period from randomization to death for any cause (for patients who have been loss to follow-up prior to death, the last follow-up time is calculated as the time of death).
Progression free survival (PFS): The duration from randomization to the earliest date of the date of tumor progression or the date of death for any cause. If the above standards are not met, the final evaluation date should be used for analysis.
Assessment of lymphedema in lower extremities: Lymphedema Staging standards (Stage 0-3) according to the"consensus document"of the International Society of Lymphology were used :
Stage 0 Subclinical with possible clinical evolution Stage I Edema regressing with treatments with positive pitting test Stage II Edema partially regressing with treatments with negative pitting test Stage III Elephantiasis with cutaneous complications and recurrent infections.
6. Follow up The patients were followed up every 3 months for the first year, every 4 months for the second year and every 6 months from the third year.
In addition to routine oncologic follow-up, the stage of patients̛ lower extremity lymphedema should also be evaluated.
日付
| 最終確認済み: | 08/31/2017 |
| 最初に提出された: | 09/11/2017 |
| 提出された推定登録数: | 09/23/2017 |
| 最初の投稿: | 09/27/2017 |
| 最終更新が送信されました: | 09/23/2017 |
| 最終更新日: | 09/27/2017 |
| 実際の研究開始日: | 08/31/2017 |
| 一次完了予定日: | 08/31/2018 |
| 研究完了予定日: | 08/31/2020 |
状態または病気
介入/治療
Procedure: Experimental group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| No Intervention: Control group IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy | |
| Experimental: Experimental group IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection. | Procedure: Experimental group Radical hysterectomy and selective enlarged lymph node dissection |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | Female |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma. 2. histological grading of cervical cancer is 1, 2, 3 or not. 3. patients in the group must have no reproductive function requirements. 4. Patients must be ≥ 18 years of age. 5. preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement. Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing. 6. Signed informed consent. 7. Surgery should be completed within 4 weeks after the first diagnosis. 8. patients can receive treatment and follow-up. Exclusion Criteria: 1. abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis. 2. other history of the tumor, but does not include: received appropriate treatment of non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence. 3. Those who have received or will receive neoadjuvant chemotherapy. 4. patients with preoperative limb lymphedema or lower extremity venous and lymphatic reflux disorders. 5. pregnant women |
結果
主な結果の測定
1. Overall survival (OS) [3 year]
二次的な結果の測定
1. Progression-Free-Survival (PFS) [3 year]
2. Lower extremities lymphedema [3 year]
