Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase II Randomized Trial of PET Imaging in Assessing Response to Induction Chemotherapy in Esophageal Squamous Cell Carcinoma Treated With Definitive Chemoradiotherapy
Since multiple studies have demonstrated that PET can identify responders and non-responders to induction chemotherapy, using FDG-PET imaging to guide treatment decisions has prompted interest in clinical practice. The aim of this study was to evaluate whether changing chemotherapy regimen during radiation based on PET response to induction chemotherapy can improve clinical complete response (cCR) in patients with unresectable esophageal squamous cell carcinoma (ESCC).
Status | Recruiting |
Enrollment | 216 |
Est. completion date | December 2023 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Histologically confirmed squamous cell carcinoma of the esophagus; 2. Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8); 3. Not suitable for surgery (either for medical reasons or patient's choice); 4. Age at diagnosis 18 to 70 years; 5. Eastern Cooperative Oncology Group performance status = 2 6. No prior cancer therapy; 7. No history of concomitant or previous malignancy; 8. Hematologic function: WBC = 4.0×109/L, PLT = 80×109/L, Hb = 10mg/dL; 9. Renal function: Cr = 1.25×UNL; 10. Hepatic function: BIL = 1.5×UNL, ALT/AST = 2.5×UNL; 11. Documented informed consent to participate in the trial. Exclusion Criteria: 1. Younger than 18 or older than 70 years of age; 2. ECOG performance status of 3 or above; 3. Other cancer history; 4. Previous radiotherapy history; 5. Subjects with distant metastases; 6. Pregnancy or breast feeding. Women of childbearing age must use effective contraception; 7. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension); 8. Evidence of bleeding diathesis or serious infection. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guanzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Mian XI |
China,
Ku GY, Kriplani A, Janjigian YY, Kelsen DP, Rusch VW, Bains M, Chou J, Capanu M, Wu AJ, Goodman KA, Ilson DH. Change in chemotherapy during concurrent radiation followed by surgery after a suboptimal positron emission tomography response to induction chem — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical complete response | RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on CT or PET-CT scans, endoscopy with biopsies. | 3 months after the treatment (plus or minus 7 days) | |
Secondary | Overall survival | From the enrollment to the date of death from any cause or date of lost follow-up | 3 years after randomization | |
Secondary | Progression-free survival | From the date of randomization to the date of disease progression or last follow-up | 3 years after randomization | |
Secondary | Chemoradiotherapy-related toxicity | Treatment-related toxicity | From the date of randomization to the 3 months after treatment |
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