Description:

A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01391572

Link:

https://clinicaltrials.gov/show/NCT01391572

Keywords:
Versions (1) ▾
  1. 12/14/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

December 14, 2019

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License:
Creative Commons BY 4.0
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Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

Eligibility Esophageal Squamous Cell Carcinoma NCT01391572

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