Status:
UNKNOWN
PET Imaging-guided Chemoradiotherapy in Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Mian XI
Conditions:
Neoplasm, Esophageal
Squamous Cell Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 clin...
Detailed Description
A total of 216 patients with baseline PET scan were randomized to one of 2 induction chemotherapy arms: paclitaxel/cisplatin (TP) on days 1, 22 or FOLFOX (oxaliplatin, leucovorin, 5-FU) on days 1, 15,...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma of the esophagus;
- Absence of hematogenous metastasis disease, confirmed by endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
- Not suitable for surgery (either for medical reasons or patient's choice);
- Age at diagnosis 18 to 70 years;
- Eastern Cooperative Oncology Group performance status ≤ 2
- No prior cancer therapy;
- No history of concomitant or previous malignancy;
- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
- Renal function: Cr ≤ 1.25×UNL;
- Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
- Documented informed consent to participate in the trial.
Exclusion
- Younger than 18 or older than 70 years of age;
- ECOG performance status of 3 or above;
- Other cancer history;
- Previous radiotherapy history;
- Subjects with distant metastases;
- Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
- Evidence of bleeding diathesis or serious infection.
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03791905
Start Date
January 15 2019
End Date
December 1 2023
Last Update
March 23 2021
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China, 510060