Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

• Status: Completed
• Trial end date: 2020-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mian XI
• Treatments: Cisplatin; Docetaxel

Criteria

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.