NCT01179074

Brief Summary

To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
Last Updated

August 11, 2010

Status Verified

February 1, 2010

Enrollment Period

1.9 years

First QC Date

May 25, 2010

Last Update Submit

August 10, 2010

Conditions

Oesophageal Cancer

Keywords

palliation inoperable oesophageal cancer

Outcome Measures

Primary Outcomes (3)

  • Relief of dysphagia

    Relief of dysphagia will be assessed by stratifying the ability to swallow into the following grades. Grade 1: Difficulty in swallowing solid food Grade 2: Difficulty in swallowing semisolid food Grade 3: Difficulty in swallowing liquids Grade 4: Difficulty in swallowing even saliva The dysphagia scores will be assessed 1 week after intervention (stenting and radiotherapy)in the two groups

    1 week after intervention

  • Relief of dysphagia

    Dysphagia grades at 3 months will be assessed in the two groups

    3 months following intervention

  • Relief of dysphagia

    Dysphagia grades at 5 months will be assessed in the two groups

    5 months after intervention

Secondary Outcomes (1)

  • Survival

    From the date of diagnosis till death

Study Arms (2)

Oesophageal stent alone

ACTIVE COMPARATOR

Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents

Procedure: oesophageal stenting with self expandable metal stent

Oesophageal stent followed by EBRT

ACTIVE COMPARATOR

Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks)

Procedure: oesophageal stenting with self expandable metal stentProcedure: Oesophageal stent followed by external beam radiotherapy

Interventions

oesophageal stenting with self expandable metal stentPROCEDURE

oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer

Also known as: Ultraflex stent, Microvasive, Boston Scientific
Oesophageal stent aloneOesophageal stent followed by EBRT
Oesophageal stent followed by external beam radiotherapyPROCEDURE

30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group

Also known as: External beam radiotherapy
Oesophageal stent followed by EBRT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
  • Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.

You may not qualify if:

  • Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (1)

  • Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7.

    PMID: 7694321BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Tushar K Chattopadhyay, MS

    Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2010

First Posted

August 11, 2010

Study Start

April 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 11, 2010

Record last verified: 2010-02

Locations

IN(1)