A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, open-label, phase III trail comparing adjuvant chemoradiotherapy (Paclitaxel and carboplatin) to adjuvant radiotherapy in patients undergoing radical esophagectomy for pathologic lymph node positive esophageal squamous cell carcinoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically documented squamous cell carcinoma of the thoracic esophagus; undergoing radical esophagectomy; the pathological stage is T(primary tumor)1-4 N(regional lymph nodes)1-3 M(distant metastasis)0 (ESOPHAGUS, Union for International Cancer Control(UICC) 2010) ;

2. Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);

3. The expectation of life is more than 6 months;

4. Age: 18~70 years old;

5. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin≥90g/l, normal liver/kidney function);

6. ECOG (Eastern Cooperative Oncology Group) : 0-1;

7. Able to understand this study and have signed informed consent.

Exclusion Criteria:

1. Have been treated with chemotherapy, radiotherapy and other anti tumor treatment except surgery;

2. Known or suspected of allergy to paclitaxel or carboplatin;

3. Female in pregnancy or lactating;

4. With significant psychological, family, social and other factors which may affect the ability to understand and sign the informed consent;

5. Patients with peripheral neuropathy(CTC grade≥2);

6. With other malignant tumors before the recruitment.

7. The researchers consider that the patient is not appropriate to enroll the study;

8. The patient can't be tolerant to postoperative adjuvant radiotherapy and chemotherapy for serious heart/lung/liver/kidney function, the haematopoietic system diseases, the immune system diseases, the nervous system diseases, cachexia and so on.