JPRN-jRCTs041190042
Recruiting
Phase 3
Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer ; a phase 3 trial - AFTER trial
Furusawa Akiko0 sites250 target enrollmentJune 17, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Patients with high-recurrent risk, stage IB-IIB cervical cancer after radical hysterectomy
- Sponsor
- Furusawa Akiko
- Enrollment
- 250
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Primary FIGO stage IB1,IB2,IIA1,IIA2, and IIB cervical cancer after radical hysterectomy
- •2\)Squamous cell carcinoma(SCC), adenocarcinoma, or adenosquamous cell carcinoma
- •3\)Histologically pelvic lymph node metastasis and/or parametrial invasion
- •4\)No metastasis to sites other than pelvic lymph node (swelling of more than 10 mm in shorter diameter) or no distant metastasis is found in chest/upper abdominal/pelvic enhanced CT or PET/CT performed within 56 days before surgery.Plain CT is permitted in case of allergy or asthma.
- •5\)No pathological lymph node metastasis is found in any lymph node other than pelvic lymph node.
- •6\)Type III radical hysterectomy is performed, and all of the following criteria are satisfied:
- •a)No macroscopic residual tumor with negative surgical margin (intraepithelial neoplasia is allowed)
- •b)More than 20 pathologically resected pelvic lymph nodes
- •c)Transverse cervical ligament is resected
- •d)More than 2 cm of paravaginal tissue/vagina resection length in resected specimen (before fixation)
Exclusion Criteria
- •1\)Residual tumor (including positive surgical margin).
- •2\)Metastasis to the para\-aortic node(pathological diagnosis or swelling of more than 10 mm in shorter diameter on CT image).
- •3\)Have adnexal metastasis.
- •4\)Have peritoneal metastasis
- •5\)Have postoperative infection requiring systemic treatment.
- •6\)Have serious concomitant conditions (e.g., liver/kidney/heart diseases, myelosuppression, infection).
- •7\)Have intestinal paralysis or intestinal obstruction.
- •8\)Suspected to have vesical fistula or rectal fistula.
- •9\)Have concurrent diabetes mellitus (DM) under treatment or uncontrolled DM
- •10\)Suspected to have interstitial pneumonia or pulmonary fibrosis on simple X\-ray or CT scan images.
Outcomes
Primary Outcomes
Not specified
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