Esophageal Cancer
Conditions
Keywords
Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy
Brief 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.
Detailed description
Patient Population: Age: 18-70y; Thoracic esophageal squamous cell cancer undergoing radical esophagectomy; Clinical stage T1-4, N1-3, M0; Eastern Cooperative Oncology Group (ECOG) score: 0-1; The patients are randomized to 2 arms. Arm A: Adjuvant radiotherapy (50.4gray/28fraction) followed by chemotherapy (Paclitaxel and carboplatin) 4 cycles. Arm B :Adjuvant radiotherapy (50.4gray/28fraction) only
Interventions
RADIATIONAdjuvant radiotherapy
Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
Sponsors
Zhejiang Cancer Hospital
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall survival | 3 years | To evaluate the 3 years overall survival of two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3 years | To evaluate the 3 years disease-free survival of two groups. |
| Adverse Events | 1 year | Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) 4.0 |
| Scores of Quality of life | 1 year | Assess the quality of life based on FACT-E |
Countries
China
Contacts
Primary ContactWeimin Mao, MD.
Backup ContactYaping Xu, MD.
Outcome results
None listed