NCT01463501

Brief Summary

This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 14, 2013

Status Verified

September 1, 2011

Enrollment Period

2.2 years

First QC Date

August 30, 2011

Last Update Submit

May 11, 2013

Conditions

Esophageal Cancer

Keywords

Esophageal cancerResectableNeoadjuvant chemoradiotherapyAdjuvant chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

  • Scores of Quality of life

    Assess the quality of life based on FACT-E.

    1 year

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Assess the safety and tolerability based on NCI CTC V4.0

    1 year

Secondary Outcomes (2)

  • Disease-free Survival

    3 years

  • Overall Survival

    3 years

Study Arms (2)

Neoadjuvant Treatment

EXPERIMENTAL

Preoperative chemotherapy/radiotherapy

Other: Neoadjuvant chemoradiotherapy

Adjuvant Treatment

EXPERIMENTAL

Postoperative chemotherapy/radiotherapy

Other: Adjuvant chemoradiotherapy

Interventions

Neoadjuvant chemoradiotherapyOTHER

Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.

Also known as: Neoadjuvant Treatment
Neoadjuvant Treatment
Adjuvant chemoradiotherapyOTHER

Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.

Also known as: Adjuvant Treatment
Adjuvant Treatment

Eligibility Criteria

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

You may qualify if:

  • Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (\> 20cm from the incisors) or gastroesophageal junction are included.
  • No distant metastases (M0).
  • Patients will be stratified by stage (clinical N0 versus clinical N1).
  • Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
  • Resectable mediastinal nodes are eligible.
  • No prior chemotherapy for this malignancy.
  • No prior radiotherapy that would overlap the field(s) treated in this study.
  • Patients with other malignancies are eligible only if \> 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
  • Age \> 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.

You may not qualify if:

  • Cancers of the cervical esophagus (\< 20 cm are excluded).
  • Tumours that have \> 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
  • Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
  • Patients with biopsy proven metastatic celiac nodes are ineligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Neoadjuvant TherapyChemoradiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsChemoradiotherapyDrug TherapyRadiotherapy

Study Officials

  • Weimin Mao, MD

    Zhejiang Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weimin Mao, MD.

CONTACT

+86-571-88122032maowmzj1218@163.com

Yaping Xu, MD.

CONTACT

+86-571-88122082xuyaping1207@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

November 2, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2016

Last Updated

May 14, 2013

Record last verified: 2011-09

Locations

CN(2)