Neoplasms
Conditions
Keywords
Esophageal cancer, Chemoradiotherapy, induction chemotherapy
Brief summary
The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.
Detailed description
108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.
Interventions
DRUGDocetaxel
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DRUGCisplatin
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RADIATIONRadiotherapy
definitive radiotherapy
Sponsors
Mian XI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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. Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and CT scan (according to UICC TNM version 6); 3. Absence of distant metastasis of solid organ; 4. Not suitable for surgery (either for medical reasons or patient's choice); 5. Age at diagnosis 18 to 70 years; 6. Eastern Cooperative Oncology Group performance status ≤ 2 7. No prior cancer therapy; 8. No history of concomitant or previous malignancy; 9. Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL; 10. Renal function: Cr ≤ 1.25×UNL; 11. Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL; 12. 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 |
|---|---|---|
| overall response rate (clinical complete response and partial response) | 3 months after chemoradiotherapy (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 barium esophagography, CT scans, and endoscopy with biopsies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years | From the date of randomization to the date of disease progression or last follow-up |
| Overall survival | 3 years | Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up |
Countries
China
Outcome results
None listed