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Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Zhejiang Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01463501
First received: August 30, 2011
Last updated: May 11, 2013
Last verified: September 2011

August 30, 2011
May 11, 2013
October 2011
December 2013   (final data collection date for primary outcome measure)
  • Scores of Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the quality of life based on FACT-E.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the safety and tolerability based on NCI CTC V4.0
Same as current
Complete list of historical versions of study NCT01463501 on ClinicalTrials.gov Archive Site
  • Disease-free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Three years disease free survival will be evaluated.
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Three years overall survival will be evaluated.
Same as current
Not Provided
Not Provided
 
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Esophageal Cancer
  • Other: Neoadjuvant chemoradiotherapy
    Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
    Other Name: Neoadjuvant Treatment
  • Other: Adjuvant chemoradiotherapy
    Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
    Other Name: Adjuvant Treatment
  • Experimental: Neoadjuvant Treatment
    Preoperative chemotherapy/radiotherapy
    Intervention: Other: Neoadjuvant chemoradiotherapy
  • Experimental: Adjuvant Treatment
    Postoperative chemotherapy/radiotherapy
    Intervention: Other: Adjuvant chemoradiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2016
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Weimin Mao, MD. +86-571-88122032 maowmzj1218@163.com
Contact: Yaping Xu, MD. +86-571-88122082 xuyaping1207@gmail.com
China
 
NCT01463501
ZhejiangCH09
Yes
Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
Not Provided
Principal Investigator: Weimin Mao, MD Zhejiang Cancer Hospital
Zhejiang Cancer Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP