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Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.

Phase 3
18 Years
81 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dysphagia relief

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Eduardo Rosenblatt, MD

Investigator Role:

Study Chair

Investigator Affiliation:

International Atomic Energy Agency


United Nations: International Atomic Energy Agency

Study ID:




Start Date:

February 2007

Completion Date:

February 2011

Related Keywords:

  • Esophageal Cancer
  • Esophageal cancer
  • Brachytherapy
  • Radiotherapy
  • Palliation
  • Dysphagia
  • Esophageal Diseases
  • Esophageal Neoplasms