Esophageal Cancer
Conditions
Keywords
Salvage therapy, Recurrence, Chemoradiation
Brief summary
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.
Detailed description
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation. Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%. Data of 218 cases of our hospital indicated patients received radiation dose \> 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had \<54Gy. The optimal radiation dose should be further investigated. The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible. The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.
Interventions
RADIATIONInvolved field irradiation
Involved field irradiation; intensity-modulated radiation therapy
RADIATIONElective field irradiation
Elective field irradiation; intensity-modulated radiation therapy
DRUGPaclitaxel
Paclitaxel 135-150mg/m2, d1, every 3 weeks
DRUGPlatinum
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
DRUGPEG-rhG-CSF
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Tianjin Medical University Cancer Institute and Hospital
Anyang Tumor Hospital
Fujian Cancer Hospital
Peking University Cancer Hospital & Institute
Hebei Medical University Fourth Hospital
Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Locoregional recurrence after radical surgery; * Positive resection margin (R1/R2) after surgery; * Out-of-field recurrence after adjuvant chemoradiation or radiotherapy; * Recurrence after adjuvant chemotherapy; * No prior therapy after recurrence; * Age 16-70 years; * KPS\>70; * No history of drug allergy; * Sufficient liver and kidney functions; * White blood cell count \> 4.0\*10\^9/L.
Exclusion criteria
* Age\>70 or \<16 years; * Pregnancy or lactation; * History of drug allergy; * Declining informed consent; * Insufficient liver or kidney functions, or abnormal CBC test; * Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-, 2-, 3-year overall survival | From treatment initiation to death from any cause or censor, assessed up to 36 months | Overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-, 2-, 3-year local progression-free survival | From treatment initiation to first documented local progression or death or censor, assessed up to 36 months | Local progression-free survival |
| 1-, 2-, 3-year progression-free survival | From treatment initiation to first documented progression or death or censor, assessed up to 36 months | Progression-free survival |
| Simultaneously integrated boost radiation therapy completion rate | During chemoradation, assessed up to 60 days | Radiation therapy completion rate |
| Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities | Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities | Toxicities of chemoradiation therapy |
Countries
China
Contacts
Primary ContactZefen Xiao, MD
Backup ContactLei Deng, MD
Outcome results
None listed