Palliation Dysphagia Cancer Oesophagus Stent+Brachytherapy Versus Brachytherapy Only

NCT00653107 | Terminated Phase 3

• 2 other identifiers: FO2007/45S-07447a
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

We wish to improve the swallowing function of patients with advanced cancer of the oesophagus, by carrying out a randomised clinical study in which we compare primary stenting followed by brachytherapy in the stent, 8 G x 3 with standard brachytherapy 8 Gy x 3. The aim of the study is to investigate whether patients who receive a stent followed by brachytherapy have a better swallowing function without more pain at week +2,compared to patients who receive brachytherapy alone.

Conditions

Esophageal Neoplasm

Keywords

Palliation; Cancer oesophagus; Stent; Brachytherapy; Randomized

Outcome Measures

Primary Outcomes (1)

• Dysphagia measured with the dysphagia grading scale at week +2 after start of treatment. Pain at rest measured with ESAS at week +2 after start of treatment.

  8 years

Secondary Outcomes (1)

• Health related quality of life

  8 years

Study Arms (2)

A

EXPERIMENTAL

Stent followed by 3 brachytherapy fractions

Procedure: Stent insertion; Radiation: Brachytherapy

B

ACTIVE COMPARATOR

3 fractions of brachytherapy

Radiation: Brachytherapy

Interventions

Stent insertion PROCEDURE

Self-expanding metal stents will be used. These will be of the type which the hospital at any given time uses, at present Ultraflex®.

A

Brachytherapy RADIATION

a flexible applicator (with a diameter adapted to the stent's diameter) will be introduced into the oesophagus, so the applicator will be lying in the middle of the lumen of the stent. Thereafter, the flexible applicator is connected to a MicroSelectron afterloading device (Iridium-192), and the treatment is given with a high dose rate (\> 12 Gy/h).

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must fulfill all the following criteria:
• Histologically or cytologically verified carcinoma of the oesophagus
• Reduced ability to swallow solid food, minimum grade 1 (see page 16)
• Age ≥ 18 years
• Ability to understand and answer (with or without help) the study questionnaires
• Written informed consent received
• A Completed questionnaire received from the patient
• One of the following criteria must be fulfilled:
• Advanced disease and WHO performance status ≥2
• Advanced disease and WHO performance status 0-1 and other therapy excluded due to medical condition
• Advanced disease and WHO performance status 0-1 and patient's preference
• Local disease and WHO performance status ≥2 and other therapy excluded due to medical condition
• Local disease and WHO performance status ≥2 and patient's preference

You may not qualify if:

• Oesophageal stent already inserted
• Endoscopic procedures not tolerated
• Cannot have (additional) radiation therapy
• Tumour location not suited for stent or brachytherapy (the upper 3 cm of oesophagus or major component in the cardia)

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Cancer Society: collaborator
• Norwegian Foundation for Health and Rehabilitation: collaborator

Study Sites (1)

Radiumhospitalet

Oslo, N-0310, Norway

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Kristin Bjordal, PhD

  Radiumhospitalet. Rikshospitalet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

NO (1)