Clinical trial NCT02325986: Concurrent Radiotherapy and Weekly Chemotherapy of PF for Postoperative Locoregional Recurrence of Esophageal Cancer
Official title: Concurrent Radiotherapy and Weekly Chemotherapy of 5-fluorouracil and Cisplatin for Postoperative Locoregional Recurrence of Oesophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: radiotherapy
esophageal carcinoma
chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall response rate
timeFrame: within 8 weeks after the treatment(plus or minus 5 days)
Secondary outcomes:
measure: safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).
timeFrame: up to 3 years
measure: overall survival
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SYSU Cancer Center
state: Guangdong
Study officials:
affiliation: Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, P.R. China
name: Yujia Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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