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Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01463501
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
62
Duration (Months)
30
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neoadjuvant chemoradiotherapy
  • Other: Adjuvant chemoradiotherapy
 Phase 2

Detailed Description

Patient Population:

Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0

Scheme:
Patients are randomized to 2 arms:
Arm A:

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

Arm B:

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Oct 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2013
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neoadjuvant Treatment

Preoperative chemotherapy/radiotherapy

Other: Neoadjuvant chemoradiotherapy
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Other Names:
  • Neoadjuvant Treatment

    		•
    Experimental: Adjuvant Treatment

    Postoperative chemotherapy/radiotherapy

    Other: Adjuvant chemoradiotherapy
    Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
    Other Names:
  • Adjuvant Treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Scores of Quality of life [1 year]

      Assess the quality of life based on FACT-E.

    2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [1 year]

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

    Secondary Outcome Measures

    1. Disease-free Survival [3 years]

      Three years disease free survival will be evaluated.

    2. Overall Survival [3 years]

      Three years overall survival will be evaluated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    2 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022

    Sponsors and Collaborators

    • Zhejiang Cancer Hospital

    Investigators

    • Principal Investigator: Weimin Mao, MD, Zhejiang Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhejiang Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT01463501
    Other Study ID Numbers:
    • ZhejiangCH09
    First Posted:
    Nov 2, 2011
    Last Update Posted:
    May 14, 2013
    Last Verified:
    Sep 1, 2011
    Keywords provided by Zhejiang Cancer Hospital
    Esophageal cancer
    Resectable
    Neoadjuvant chemoradiotherapy
    Adjuvant chemoradiotherapy
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of May 14, 2013