Adjuvant Chemotherapy Versus Radiotherapy For Postoperative Cervical Cancer ; a phase 3 trial

JRCT ID: jRCTs041190042

Registered date:17/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with high-recurrent risk, stage IB-IIB cervical cancer after radical hysterectomy
• Date of first enrollment: 20/02/2020
• Target sample size: 250
• Countries of recruitment: Korea,Japan
• Study type: Interventional

Intervention(s)

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) for six cycles after radical hysterectomy

Outcome(s)

• Primary Outcome: Overall survival

Secondary Outcome

Disease free survival (DFS)
Adverse events and severe adverse events
QOL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include criteria

1)Primary FIGO stage IB1,IB2,IIA1,IIA2, and IIB cervical cancer after radical hysterectomy
2)Postoperative tissue specimen with pathologic di
agnosis of one of the following histologic types
Squamous cell carcinoma (HPV-associated, HPV-ind
ependent, NOS)
Adenocarcinoma (NOS, HPV-associated,
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 performed within 63 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 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.
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

Exclude 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.

Related Information

• Primary Sponsor: Furusawa Akiko
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group.