Tri-weekly Cisplatin Based Chemoradiation in Locally Advanced Cervical Cancer

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Current standard treatment for locally advanced cervical cancer is cisplatin-based concurrent chemoradiation (CRT). Although recently reported meta-analysis studies also demonstrated improved local control rates and survival with cisplatin-based chemotherapy concurrent to radiation therapy (RT), the optimal cisplatin dose and dosing schedule are still undetermined.

In light of the results of the previous clinical trial, weekly cisplatin 40 mg/m2 considered to be a standard regiment in cisplatin doses and dosing schedules. However, our randomized phase II trial showed that tri-weekly cisplatin 75mg/m2 has lower toxicities and a better outcome in locally advanced cervical cancer.

In this randomized phase III trial, the investigators investigate that there may be a survival difference between weekly cisplatin 40 mg/m2 and tri-weekly cisplatin 75 mg/m2 administration concurrent to RT in cervical cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Cancer Center Hospital
• Collaborators: Asan Medical Center; Gangnam Severance Hospital; Seoul National University Hospital
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Eligible patients will have pathologically proven primary locally advanced cervical cancer with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma histology suitable for primary treatment with chemoradiation with curative intent

• FIGO 2008 stage 1B2, 2B, 3B, 4A

• Age 18 years or older

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Patients must have adequate Hematologic function(ANC ≥ 1,500/mcl and platelets ≥ 100,000/mcl), Renal function(serum creatinine ≤ ULN or calculated creatinine clearance ≥ 60 mL/min), Hepatic function(serum bilirubin ≤ 1.5 x ULN and AST ≤ 2.5 x ULN and ALT≤ 2.5 x ULN)

• Patients must have signed an approved informed consent

Exclusion Criteria:

• Patients with cervix cancer who have received any previous radiation or chemotherapy

• Patients assessed at presentation as requiring interstitial brachytherapy treatment

• FIGO stage 3A disease

• Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive or > 15mm short axis diameter on CT)

• Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria

• Previous chemotherapy for this tumor

• Evidence of distant metastases

• Prior diagnosis of Crohn's disease or ulcerative colitis

• Patients who are pregnant or lactating

• History of other invasive malignancies, with the exception of non-melanoma skin cancer and in situ melanoma, who had (or have) any evidence of the other cancer present within the last 5 years

• Serious illness or medical condition that precludes the safe administration of the trial treatment including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements