Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer ; a phase 3 trial
- Conditions
- Patients with high-recurrent risk, stage IB-IIB cervical cancer after radical hysterectomyCervical cancer
- Registration Number
- JPRN-jRCTs041190042
- Lead Sponsor
- Furusawa Akiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 250
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)
e)Surgery was performed by operators who satisfied all of the following requirements:(Limited to sistes in Japan)
i.The surgeon-investigator is a gynecologic oncologist of the Japan Society of Gynecologic Oncology.
ii. The surgeon is a gynecologic oncologist or a gynecologic specialist of the Japan Society of Obstetrics and Gynecology.
7)The age at registration is over 20 years old and under 75 years old.
8)Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
9)Within 42 days after surgery.
10)Initial treatment ( no past history of radiation or neoadjuvant chemotherapy)
11)Functions of the major organs (e.g., bone marrow, heart, liver, kidney) are maintained.
12)Written informed consent
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.
11)Active double cancer or double cancer with disease-free period of within 5 years.
However, carcinoma in situ or lesions equivalent to intramucosal carcinoma judged to have been cured by local treatment will not be included in active double cancers.
12)Have a past history of serious drug hypersensitivity.
13)Contraindicated with paclitaxel, carboplatin, or cisplatin.
14) Have a peritoneal or pleural fluid retention requiring treatment.
15) HBs antibody positive or HCV positive.
16) HIV antibody positive.
17) Have received continuous treatment with systemic steroid (oral or intravenous).
18) Have a past history of hypersensitivity to preparations containing polysorbate 80, preparations containing polyoxyethylene castor oil (Cremophor EL) (e.g., ciclosporin), and preparations containing hydrogenated castor oil (e.g., vitamins for injection).
19) Determined to be ineligible by the principal investigator.
20) Whilie breast-feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Disease free survival (DFS)<br>Adverse events and severe adverse events<br>QO