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

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fluorouracil
Cisplatin
Intensity-modulated radiation therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring radiotherapy, esophageal carcinoma, chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SYSU Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Weekly PF with radiation

Arm Description

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).

Outcomes

Primary Outcome Measures

overall response rate
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

safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).
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
A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up

Full Information

First Posted
December 16, 2014
Last Updated
November 19, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02325986
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
radiotherapy, esophageal carcinoma, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weekly PF with radiation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3,repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3,repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
Intervention Type
Radiation
Intervention Name(s)
Intensity-modulated radiation therapy
Other Intervention Name(s)
IMRT
Intervention Description
cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3,repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
Primary Outcome Measure Information:
Title
overall response rate
Description
RECIST (Response Evaluation Criteria in Solid Tumors) was used to determine the tumor response. Tumor response was evaluated by CT 8 weeks after chemoradiotherapy.
Time Frame
within 8 weeks after the treatment(plus or minus 5 days)
Secondary Outcome Measure Information:
Title
safety: Toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v3.0).
Description
A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up
Time Frame
up to 3 years
Title
overall survival
Description
A 3 years follow-up from the enrollment or to the date of death from any cause or date of lost follow-up
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Absence of previous thoracic radiotherapy. 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). Absence of distant metastasis at recurrence. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2 Exclusion Criteria: Younger than 18 or older than 70 years of age. Eastern Cooperative Oncology Group (ECOG) performance status of 3 or above Other cancer history. Serious cardiac, liver, or pulmonary disease. Previous radiotherapy history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yujia Zhu, MD
Phone
86-20-87343385
Email
zhuyuj@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yujia Zhu, MD
Organizational Affiliation
Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, P.R. China
Official's Role
Principal Investigator
Facility Information:
Facility Name
SYSU Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yujia Zhu, Phd.
Phone
18520121368
Email
sysucc@sysucc.org.cn

12. IPD Sharing Statement

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

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