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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
Hangzhou Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Cytologically or histologically confirmed esophageal carcinoma
  2. Age of 20 -80
  3. ECOG performance status: 0-1;
  4. No treatments prior to enrollment;
  5. At least one measurable lesion on CT, MRI or esophageal barium exam;
  6. Normal functions of heart, lung, liver, kidney and bone marrow
  7. 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
  8. Informed consent signed

Exclusion Criteria:

  1. Prior treatments of chemotherapy or irradiation;
  2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
  3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
  4. Participating in other clinical trials;
  5. Pregnancy, breast feeding, or not adopting birth control;
  6. 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
  7. 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

    First Posted
    November 16, 2015
    Last Updated
    February 14, 2016
    Sponsor
    Hangzhou Cancer Hospital
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    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
    background

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