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

Phase 3

• Conditions: Esophageal Cancer
• Interventions: Radiation: Adjuvant radiotherapy; Drug: Paclitaxel and carboplatin

• Registration Number: NCT02570893
• Lead Sponsor: Zhejiang Cancer Hospital

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

Study Timeline

• Study Start: 2015-05
• Status Verified: 2015-10
• Study First Submitted: 2015-10-03
• Study First Submitted QC: 2015-10-06
• Last Update Submitted: 2015-10-06
• Study First Posted: 2015-10-07
• Last Update Posted: 2015-10-07
• Primary Completion: 2017-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adjuvant radiotherapy	Adjuvant radiotherapy	Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
adjuvant chemoradiotherapy	Paclitaxel and carboplatin	Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
adjuvant chemoradiotherapy	Adjuvant radiotherapy	Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.

Primary Outcome Measures

Name	Time	Method
The overall survival	3 years	To evaluate the 3 years overall survival of two groups.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China