A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any N, M0).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Affiliated Hospital of Jiangsu University; Anhui Provincial Hospital; First Affiliated Hospital of Wenzhou Medical University; Fujian Cancer Hospital; Jiangsu Cancer Institute & Hospital; RenJi Hospital; Shanghai Chest Hospital; Shanghai Pulmonary Hospital, Shanghai, China; The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Soochow University; Zhejiang Cancer Hospital; Zhejiang University
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤70

2. Performance status 0-1

3. Weight is not less than 90% of it before operation

4. Registration within 8 weeks after esophagectomy

5. Histologically proven primary thoracic esophageal squamous cell carcinoma

6. R0 resection and number of lymph nodes dissected ≥15 after esophagectomy

7. Pathological stage of T3-4N0-3M0

8. Chest and abdominal contrast enhanced CT within 6 weeks prior to registration(PET/CT scan is selective)

9. Without supraclavicular nodes and abdominal regions nodes existed after surgery

10. Without neo-adjuvant chemotherapy and radiotherapy

11. WBC≥ 4.0X109/L ,Absolute neutrophil count (ANC) ≥ 2.0X109/L

12. Platelets ≥ 100X109/L

13. Hemoglobin ≥ 90g/L(without blood transfusion)

14. AST (SGOT)/ALT (SGPT) ≤ 2.5 x upper limit of normal, Bilirubin ≤ 1.5 x upper limit of normal

15. Creatinine ≤ 1.5 x upper limit of normal

16. Sign study-specific informed consent prior to study entry

Exclusion Criteria:

1. Multiple primary esophageal tumors

2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).

3. Severe, active comorbidity, defined as follows:

3.1 Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months 3.2 Transmural myocardial infarction within the last 6 months 3.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration 3.5 Acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

4. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.

5. Prior systemic chemotherapy, prior radiation therapy or prior target drug therapy