Patients with high-recurrent risk, stage IB-IIB cervical cancer after radical hysterectomy Cervical cancer
Conditions
Interventions
Arm A includes patients undergoing cisplatin based chemo-radiation after radical hysterectomy
Arm B includes patients for chemotherapy using TC (paclitaxel, carboplatin) or TP(cisplatin, paclitaxel) f
Sponsors
Furusawa Akiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Primary FIGO stage IB1,IB2,IIA1,IIA2, and IIB cervical cancer after radical hysterectomy. 2) Postoperative tissue specimen with pathologic diagnosis of one of the following histologic types. Squamous cell carcinoma (HPV-associated, HPV-independent, NOS) Adenocarcinoma (NOS, HPV-associated,HPV-independent, gastric type,HPV-independent, clear cell type,HPV-independent, mesonephric type,endometrioid adenocarcinoma) Adenosquamous carcinoma Undifferentiated 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 shorterdiameter) or no distant metastasis is found in chest/upper abdominal/pelvic enhanced CT or PET/CT or PET/MRI performed within 84 days before surgery. *Plain CT is permitted in case of allergy or asthma. *Confirmation of pelvic lymph nodes and distant metastasis by contrast-enhanced CT of the chest, upper abdomen, or pelvis may be substituted for confirmation of FDP accumulation by PET/CT of the same region. *Simple CT is acceptable in the case of contrast-enhanced patients with allergies to contrast media or bronchial asthma. *If CT is performed within 63 to 84 days prior to surgery, CT re-evaluation is recommended before the start of protocol treatment to confirm the presence of distant lesions. 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: *Quasi-extensive total hysterectomy is acceptable in cases where the tumor diameter is 2 cm or less. a) No macroscopic residual tumor with negative surgical margin (intraepithelial neoplasia isallowed) b) More than 15 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), or a sufficient distance from the tumor margins to the cut edge. *For cases in which a quasi-extended total hysterectomy was performed, the length should be 1.5 cm or more. 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 agynecologic specialist of the Japan Society of Obste trics and Gynecology. 7) The age at registration is over 20 years old. 8) Eastern Cooperative Oncology Group (ECOG) per formance status score is 0 or 1. 9) Within 56 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. Neutrophil count 1500/mm3 or higher Platelet count 100,000/mm3 or higher Hemoglobin 10.0 g/dL or higher (post-transfusion values are also acceptable) AST (GOT) and ALT (GPT) less than 100IU/L Total bilirubin 1.5 mg/dL or less Serum creatinine 1.2 mg/dL or less Ccr (Modified Jelliffe formula) 50mL/min or more Ccr (Modified Jelliffe equation) 50mL/min or more EKG normal or changes not requiring treatment 12)Written informed consent
Exclusion criteria
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. 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 antigen positive, HCV antibody positive and HCV-RNA positive. If HCV antibody positive, HCV-RNA negative is eligible. HCV-RNA measurement is not required if HCV antibody negative. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease free survival (DFS) Adverse events and severe adverse events QOL | — |
Countries
Japan, Korea
Contacts
Public ContactAkiko Furusawa
Shizuoka Cancer Center
Outcome results
None listed