Overview
A Phase II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Description
Concurrent chemoradiotherapy (CCRT) was the standard treatment for locoregionally advanced cervical cancer, while the incidence of treatment failure is still high. Adjuvant chemotherapy or inducing chemotherapy addition to CCRT did not significantly improve patient survival compared to CCRT alone. Hence, there is a need for novel therapies to improve survival for these patients.
Accumulating evidence shows that tumor-infiltrating lymphocytes (TILs) selected for tumor recognition and greatly expanded in vitro are effective for treating cervical cancer patients.
This is a phase II trial to study the effectiveness and security of cisplatin concurrent chemoradiotherapy plus TIL versus cisplatin concurrent chemoradiotherapy only in treating patients with FIGO stage IIIA to IVA cervical carcinoma.
Eligibility
Inclusion Criteria:
- Patients with histologically proven squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervical uteri
- Patients with stage IIIA-IVA cervical cancer according to the International Federation of Gynecology and Obstetrics (FIGO)
- Patients who were 18 and 65 years old
- Patients with an ECOG performance status of 0, 1, or 2
- Adequate hematological, renal, and hepatic functions defined as:
granulocytes 1.5 x 109/L, platelets 100 x 109/L, total bilirubin, ALT and AST 1.5 x upper normal limit, creatinine upper normal limit
- Patients provided written, voluntary informed consent
- Patients who were accessible to follow up and management in the treatment center
Exclusion Criteria:
- Patients with past or current history of malignancy other than the entry diagnosis except for a "cured" malignancy more than five years prior to enrollment
- Patients who received previous chemotherapy or radiotherapy
- Patients with active angina or documented myocardial infarction within the 6 months preceding registration and patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure, as well as a history of 2nd or 3rd degree heart blocks
- Patients with an active infection or other serious underlying medical conditions that would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing platinum
- Patients with dementia or altered mental status that would prohibit the understanding and providing of informed consent
- Patients with inadequate caloric and/or fluid intake