Neoplasm, Esophageal, Squamous Cell Carcinoma
Conditions
Keywords
Esophageal squamous cell carcinoma, PET, Definitive chemoradiotherapy, Induction chemotherapy
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 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).
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, 29. Repeat PET was performed on days 36-42 and changes in max standardized uptake value (SUVmax) from baseline were assessed. Using a predefined cut-off value of a 35% decrease in SUVmax, PET responders (≥35% decrease in SUVmax) continued on the same chemotherapy regimen during radiotherapy, whereas PET non-responders (\<35% decrease in SUVmax) crossed over to an alternative chemotherapy regimen concomitantly with radiation. All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is generally 50-60 Gy in 25-28 fractions, 5 days per week.
Interventions
DRUGPaclitaxel
chemotherapy drug
DRUGCisplatin
chemotherapy drug
DRUGOxaliplatin
chemotherapy drug
DRUG5-FU
chemotherapy drug
DRUGLeucovorin
chemotherapy drug
RADIATIONIntensity-modulated radiotherapy
radiotherapy technique
DEVICEPET
Using PET to evaluate response to induction chemotherapy
Sponsors
Mian XI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized parallel study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical complete response | 3 months after the treatment (plus or minus 7 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years after randomization | From the enrollment to the date of death from any cause or date of lost follow-up |
| Progression-free survival | 3 years after randomization | From the date of randomization to the date of disease progression or last follow-up |
| Chemoradiotherapy-related toxicity | From the date of randomization to the 3 months after treatment | Treatment-related toxicity |
Countries
China
Contacts
Primary ContactMian XI, MD
Backup ContactMengzhong Liu, MD
Outcome results
None listed