Concurrent Radiotherapy and Weekly Chemotherapy of PF for Postoperative Locoregional Recurrence of Esophageal Cancer

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: fluorouracil; Drug: Cisplatin; Radiation: Intensity-modulated radiation therapy

• Registration Number: NCT02325986
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-25
• Study Start: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weekly PF with radiation	Intensity-modulated radiation therapy	4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).
Weekly PF with radiation	fluorouracil	4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).
Weekly PF with radiation	Cisplatin	4 cycles of weekly cisplatin and fluorouracil (cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3, repeated weekly for 4 weeks) concurrently with Intensity-modulated radiation therapy (60Gy/28fr).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

SYSU Cancer Center; 🇨🇳 Guangzhou, Guangdong, China