Clinical trial NCT02570893: A Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Esophageal Squamous Cell Carcinoma
Official title: A Multicenter, Randomized, Open-label, Phase III Trail of Adjuvant Chemoradiotherapy Versus Adjuvant Radiotherapy in Patients Undergoing Radical Esophagectomy for Pathologic Lymph Node Positive Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Cancer
Keywords: Esophageal cancer;adjuvant therapy;chemotherapy;radiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: The overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
measure: Adverse Events
timeFrame: 1 year
measure: Scores of Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Weimin Mao, MD.
role: PRINCIPAL_INVESTIGATOR
References: