Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Atomic Energy Agency
ClinicalTrials.gov Identifier:
NCT00665197
First received: April 18, 2008
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

Hypothesis: In the management of advanced oesophageal cancer, to determine if a shorter regime of external beam radiotherapy (using higher daily doses, and combined with intraluminal high dose rate brachytherapy) is not inferior in the palliation of dysphagia than a more protracted course of external beam radiotherapy (using lower daily doses and combined with equal intraluminal high dose rate brachytherapy).


Condition Intervention Phase
Esophageal Cancer
Radiation: Protracted Course Radiotherapy
Radiation: Short Course Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Dysphagia relief [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Treatment Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: February 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Protracted Course Radiotherapy

High Dose Rate brachytherapy 8.0 Gy x 2

External beam radiotherapy 30 Gy in 10 fractions of 3.0 Gy

Radiation: Protracted Course Radiotherapy
External Beam Radiation 30 Gy in 10 fractions
Experimental: Short Course Radiotherapy

High Dose Rate brachytherapy 8.0 Gy x 2

External beam radiotherapy 20 Gy in 5 fractions of 4.0 Gy

Radiation: Short Course Radiotherapy
External Beam Radiation 20 Gy in 5 fractions

Detailed Description:

This is a prospective, pragmatic and multi-centre clinical trial, without blinding or masking to the randomly assigned treatment. Patient registration and randomization are centralized. There are two arms to the study, expecting an equal numbers of patients randomized to each arm. Stratification will by according to: (1) treating institution/country, and (2) baseline Stage (M1 = distant metastases versus M0 = no distant metastases). The primary statistical analysis will be conducted as an "intention-to-treat" clinical trial.

A cost-effectiveness analysis is not required because the main contrast is between 5 and 10 fractions of EBRT, where 5 fractions are less expensive than 10 fractions. This protocol follows the recommendations of CONSORT for the reporting of non-inferiority and equivalence trials. The active control is 30 Gy in 10 fractions, and the new therapy is 20 Gy in 5 fractions.

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Endoscopic and biopsy-proven carcinoma of the esophagus, either Adenocarcinoma or Squamous cell carcinoma;
  • Lesions of the thoracic oesophagus and the abdominal oesophagus but not involving the cardia of the stomach. (The oesophagus extends from the cricopharyngeus muscle at the level of the cricoid cartilage to the GEJ junction. The most proximate cervical oesophagus extends approximately 2-3 cm distal to the cricopharyngeus muscle approximately 18 cm from the incisors, and is excluded from this study; however the remaining oesophagus is included in this study, including the last 1-2 cm of the oesophagus which is intra-abdominal and up to the GEJ.);
  • Dysphagia immediately prior to the first HDR ILBT session (based on a 4-question summary score of 4-15 (i.e. less than a score of 16) using four of the questions from the EORTC QLQ OES-18 measure;
  • Able to insert the intra-esophageal applicator (Dilatation is allowed to open up the tumor/lumen to facilitate insertion, and this does not preclude eligibility. Any oesophageal stent must be removed prior to brachytherapy because metal stents may inappropriately increase the dose of radiation to the esophageal wall by approximately 10%.]);
  • Karnofsky is between 40 and 90, inclusive and at baseline (no patient can be 100 as all will have at least dysphagia from disease at baseline; patients with KPS <40 are not eligible for this study);
  • Eligible for radiotherapy (e.g. any pacemaker is not within 2.5 cm of the outside of the field edge for the EBRT component of therapy);
  • Signed informed consent.

Exclusion Criteria:

  • Age less than 18;
  • Patients suitable for curative treatment with either surgery or chemo-radiation;
  • Tracheo-esophageal fistula, or deep mucosal ulceration;
  • Perforation or massive esophageal bleeding ;
  • Previous treatment (e.g. chemotherapy, radiation therapy, laser therapy or surgery) for esophageal cancer (gastrostomy or PEG does not constitute exclusion criteria, and should be considered for patients with complete obstruction or where there has been substantial loss in body weight prior to diagnosis);
  • Stents in situ (i.e. not removed prior to the first HDR ILBT);
  • Previous thoracic radiation therapy for any cause, either EBRT or ILBT;
  • Evidence of other uncontrolled malignancies, or evidence of synchronous head and neck or lung primary cancers (regardless of whether those malignancies could be managed with curative intent);
  • Failure to complete all baseline assessments required for the study, including patient-elicited scores for symptoms and QOL;
  • Pregnant or lactating patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665197

Locations
Canada, Ontario
Credit Valley Hospital Statistical Centre
Credit Valley, Ontario, Canada, L5M 2N1
China, Beijing
Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Croatia
University of Zagreb Clinical Hospital
Zagreb, Croatia, 10000
India
Tata Memorial Hospital
Mumbai, Parel, India, 490 012
Pakistan
Institute of Nuclear Medicine and Oncology
Lahore, Punjab, Pakistan, 54600
South Africa
University of the Witwatersrand Department of Radiat. Oncology
Johannesburg, Parktown, South Africa, 2193
Thailand
Mahidol University Faculty of Medicine Siriraj Hospital
Bangkok, Siriraj, Thailand, 10700
Sponsors and Collaborators
International Atomic Energy Agency
Investigators
Study Chair: Eduardo Rosenblatt, MD International Atomic Energy Agency
  More Information

Additional Information:
Publications:
Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT00665197     History of Changes
Other Study ID Numbers: E3.30.27
Study First Received: April 18, 2008
Last Updated: October 12, 2011
Health Authority: United Nations: International Atomic Energy Agency

Keywords provided by International Atomic Energy Agency:
Esophageal cancer
Brachytherapy
Radiotherapy
Palliation
Dysphagia

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 29, 2014