Concurrent Chemoradiotherapy, Esophageal Cancer, Oxaliplatin, Paclitaxel
Conditions
Keywords
Esophageal cancer, Concurrent chemoradiotherapy, Oxaliplatin, Paclitaxel, Survival, Toxicity
Brief summary
This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.
Interventions
DRUGPaclitaxel
PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.
DRUGOxaliplatin
oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.
RADIATIONRadiotherapy
Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.
Sponsors
Hangzhou Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Cytologically or histologically confirmed esophageal carcinoma 2. Age of 20 -80 3. ECOG performance status: 0-1; 4. No treatments prior to enrollment; 5. At least one measurable lesion on CT, MRI or esophageal barium exam; 6. Normal functions of heart, lung, liver, kidney and bone marrow 7. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL 8. Informed consent signed
Exclusion criteria
1. Prior treatments of chemotherapy or irradiation; 2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable; 3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis; 4. Participating in other clinical trials; 5. Pregnancy, breast feeding, or not adopting birth control; 6. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities 7. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| response rate | week 4 | Response rate was done after 4 weeks following the last radiotherapy session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival outcome | year 0- year 5 | Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death. |
| Toxicity | year 0- year 5 | Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0). |
Outcome results
None listed