NCT02607982

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

9.4 years

First QC Date

November 16, 2015

Last Update Submit

February 14, 2016

Conditions

Esophageal CancerConcurrent ChemoradiotherapyOxaliplatinPaclitaxel

Keywords

Esophageal cancerConcurrent chemoradiotherapyOxaliplatinPaclitaxelSurvivalToxicity

Outcome Measures

Primary Outcomes (1)

  • response rate

    Response rate was done after 4 weeks following the last radiotherapy session.

    week 4

Secondary Outcomes (2)

  • Survival outcome

    year 0- year 5

  • Toxicity

    year 0- year 5

Study Arms (1)

Concurrent Chemoradiotherapy Arm

EXPERIMENTAL

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.

Drug: PaclitaxelDrug: OxaliplatinRadiation: Radiotherapy

Interventions

PaclitaxelDRUG

PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.

Concurrent Chemoradiotherapy Arm
OxaliplatinDRUG

oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.

Concurrent Chemoradiotherapy Arm
RadiotherapyRADIATION

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.

Concurrent Chemoradiotherapy Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 18396692BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

PaclitaxelOxaliplatinRadiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

January 1, 2005

Primary Completion

June 1, 2014

Study Completion

November 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02