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

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 3

Conditions: Esophageal Cancer

Treatments: Radiation: Adjuvant radiotherapy; Drug: Paclitaxel and carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02570893

ZTOG-1401

Details and patient eligibility

About

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.

Full 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

Enrollment: 366 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 2 patient groups

adjuvant chemoradiotherapy

Experimental group

Description:

Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.

Treatment:

Radiation: Adjuvant radiotherapy

Radiation: Adjuvant radiotherapy

Drug: Paclitaxel and carboplatin

adjuvant radiotherapy

Experimental group

Description:

Adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.

Treatment:

Radiation: Adjuvant radiotherapy

Radiation: Adjuvant radiotherapy