CCRT for Esophageal Cancer.
Primary Purpose
Esophageal Cancer, Concurrent Chemoradiotherapy, Oxaliplatin
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Oxaliplatin
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer focused on measuring Esophageal cancer, Concurrent chemoradiotherapy, Oxaliplatin, Paclitaxel, Survival, Toxicity
Eligibility Criteria
Inclusion Criteria:
- Cytologically or histologically confirmed esophageal carcinoma
- Age of 20 -80
- ECOG performance status: 0-1;
- No treatments prior to enrollment;
- At least one measurable lesion on CT, MRI or esophageal barium exam;
- Normal functions of heart, lung, liver, kidney and bone marrow
- Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- Informed consent signed
Exclusion Criteria:
- Prior treatments of chemotherapy or irradiation;
- Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
- Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
- Participating in other clinical trials;
- Pregnancy, breast feeding, or not adopting birth control;
- Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
- The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Concurrent Chemoradiotherapy Arm
Arm Description
Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
Outcomes
Primary Outcome Measures
response rate
Response rate was done after 4 weeks following the last radiotherapy session.
Secondary Outcome Measures
Survival outcome
Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Toxicity
Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Full Information
NCT ID
NCT02607982
First Posted
November 16, 2015
Last Updated
February 14, 2016
Sponsor
Hangzhou Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02607982
Brief Title
CCRT for Esophageal Cancer.
Official Title
Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Cancer Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Concurrent Chemoradiotherapy, Oxaliplatin, Paclitaxel
Keywords
Esophageal cancer, Concurrent chemoradiotherapy, Oxaliplatin, Paclitaxel, Survival, Toxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concurrent Chemoradiotherapy Arm
Arm Type
Experimental
Arm Description
Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.
Primary Outcome Measure Information:
Title
response rate
Description
Response rate was done after 4 weeks following the last radiotherapy session.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Survival outcome
Description
Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Time Frame
year 0- year 5
Title
Toxicity
Description
Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Time Frame
year 0- year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cytologically or histologically confirmed esophageal carcinoma
Age of 20 -80
ECOG performance status: 0-1;
No treatments prior to enrollment;
At least one measurable lesion on CT, MRI or esophageal barium exam;
Normal functions of heart, lung, liver, kidney and bone marrow
Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
Informed consent signed
Exclusion Criteria:
Prior treatments of chemotherapy or irradiation;
Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
Participating in other clinical trials;
Pregnancy, breast feeding, or not adopting birth control;
Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
12. IPD Sharing Statement
Citations:
PubMed Identifier
18396692
Citation
Zhang P, Xie CY, Wu SX. [Concurrent chemoradiation with paclitaxel and platinum for locally advanced esophageal cancer]. Zhonghua Zhong Liu Za Zhi. 2007 Oct;29(10):773-7. Chinese.
Results Reference
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CCRT for Esophageal Cancer.
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