Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 3

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: adjuvant treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04009265

ACRTEC UNION

Details and patient eligibility

About

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.

Full description

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.

Enrollment: 819 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants volunteer to participate the study and signed the informed consent.
2. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
3. No antineoplastic treatments before operation.
4. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
5. WHO PS score: 0-1;
6. Age and gender: 18-75 years old, male and female unlimited;
7. Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.

Exclusion criteria

1. The surgical approach is left thoracic approach;
2. Patients with severe postoperative complications who cannot receive adjuvant therapy;
3. Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer.
4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
5. Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency;
6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
7. Known or suspected allergy to chemotherapeutic drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

819 participants in 3 patient groups

Chemotherapy

Experimental group

Description:

Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.

Treatment:

Combination Product: adjuvant treatment

Chemoradiotherapy

Experimental group

Description:

5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles

Treatment:

Combination Product: adjuvant treatment

Surgery alone

No Intervention group

Description:

Surgery alone, no adjuvant treatment.