KCT0006893
Not yet recruiting
未知
Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer (AFTER): A Phase 3 Trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Konkuk University Medical Center
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Preoperative clinical stage IB1, IB2, IIA1, IIA2, or IIB cervical cancer
- •2\) In case of histological diagnosis as follows from the tumor tissue after surgery
- •\- Squamous cell carcinoma (keratinizing type, nonkeratinizing type)
- •\- Adenocarcinoma (usual type of endocervical adenocarcinoma, intestinal type of mucinous carcinoma, endometrioid carcinoma)
- •\- Adenosquamous cell carcinoma
- •3\) Pathologically confirmed pelvic lymph node metastasis or uterine chamber invasion from surgically resected tissue
- •4\) In contrast\-enhanced CT performed within 56 days before surgery, there should be no metastases other than pelvic lymph nodes (short diameter \=10 mm) or distant metastases to the chest, upper abdomen, or pelvis, even when PET/CT was performed instead of contrast\-enhanced CT Recognition. Simple CT is also permitted if it is difficult to use a contrast medium due to complications such as allergies or bronchial asthma.
- •5\) There should be no lymph node metastasis other than the surgically resected pelvic lymph node. For invasive cancer, the incision should be negative. Intraepithelial lesions in the cut plane are acceptable.
- •6\) Type III radical hysterectomy is performed by laparotomy or laparoscopy, and all of the following conditions must be met.
- •\- There should be no gross residual tumor and negative amputation
Exclusion Criteria
- •1\) Pathologically not completely resected (including positive amputation)
- •2\) Aortic lymph node metastasis (short diameter \=10 mm on pathological diagnosis or CT)
- •3\) adnexal metastasis
- •4\) peritoneal metastasis
- •5\) Surgical water infection requiring systemic treatment
- •6\) Serious comorbidities (liver/kidney/heart disease, myelosuppression, infection, etc.)
- •7\) Intestinal insufficiency or intestinal obstruction
- •8\) Bladder or rectal fistula
- •9\) Diabetes mellitus that is being treated or not controlled by continuous insulin administration
- •10\) Interstitial pneumonia or pulmonary fibrosis suspected on plain chest radiography or CT
Outcomes
Primary Outcomes
Not specified
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