Esophageal Squamous Cell Carcinoma
Conditions
Keywords
radiotherapy, esophageal carcinoma, chemotherapy
Brief summary
The purpose of this study is to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy of 5-FU and cisplatin in patients with postoperative locoregional recurrence of esophageal squamous cell carcinoma.
Detailed description
The most optimal management for postoperative locoregional recurrence of oesophageal squamous cell carcinoma is still controversial. Several studies have reported the feasibility and efficacy of concurrent chemoradiotherapy (CCRT), mostly with three-weekly or four-weekly schedule of chemotherapy. However, treatment compliance was not quite satisfactory, probably due to treatment-related toxicities. Since CCRT with weekly chemotherapy regimens have demonstrated a favorable toxicity profile as well as promising survival in certain types of cancer, the investigators aimed to evaluate the efficacy and toxicity of radiotherapy concurrently with weekly chemotherapy with 5-fluorouracil (5-FU) and cisplatin for patients with postoperative locoregional recurrence of oesophageal squamous cell carcinoma in the investigators center.The prescribed dose of radiotherapy is generally 60Gy/28fr to tumor and 50Gy/28fr to the clinical target volume.The concomitant chemotherapy is cisplatin 25mg/m2 on day 1, 5-FU 1176mg/m2 on day 1-3, repeated weekly for 4 weeks.
Interventions
DRUGfluorouracil
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
DRUGCisplatin
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
RADIATIONIntensity-modulated radiation therapy
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. R0 resection for primary esophageal squamous cell carcinoma with two-incision esophagectomy (Ivor Lewis approach)25 or three-incision (right thoracotomy, midline laparotomy and left cervical incisions) esophagectomy with cervical esophagogastric anastomosis. 2. Absence of previous thoracic radiotherapy. 3. Cervical and/or thoracic postoperative recurrence (biopsy proven or positron emission tomography/computed tomography (PET/CT) proven or follow-up computed tomography (CT) showed progression of disease). 4. Absence of distant metastasis at recurrence. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
Exclusion criteria
1. Younger than 18 or older than 70 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above 3. Other cancer history. 4. Serious cardiac, liver, or pulmonary disease. 5. Previous radiotherapy history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | within 8 weeks after the treatment(plus or minus 5 days) | RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0). | up to 3 years | A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up |
| overall survival | up to 3 years | A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up |
Countries
China
Contacts
Primary ContactYujia Zhu, MD
Outcome results
None listed