NCT00665197

Brief Summary

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).

Trial Health

93
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2007

Typical duration for phase_3

Geographic Reach
7 countries

7 active sites

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

February 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

4 years

First QC Date

April 18, 2008

Last Update Submit

October 12, 2011

Conditions

Esophageal Cancer

Keywords

Esophageal cancerBrachytherapyRadiotherapyPalliationDysphagia

Outcome Measures

Primary Outcomes (1)

  • Dysphagia relief

    3 years

Secondary Outcomes (2)

  • Quality of life

    3 years

  • Treatment Toxicity

    3 years

Study Arms (2)

Protracted Course Radiotherapy

ACTIVE COMPARATOR

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

Short Course Radiotherapy

EXPERIMENTAL

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

Interventions

Protracted Course RadiotherapyRADIATION

External Beam Radiation 30 Gy in 10 fractions

Protracted Course Radiotherapy
Short Course RadiotherapyRADIATION

External Beam Radiation 20 Gy in 5 fractions

Short Course Radiotherapy

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 ;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Credit Valley Hospital Statistical Centre

Credit Valley, Ontario, L5M 2N1, Canada

Location

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

University of Zagreb Clinical Hospital

Zagreb, City of Zagreb, 10000, Croatia

Location

Tata Memorial Hospital

Mumbai, Parel, 490 012, India

Location

Institute of Nuclear Medicine and Oncology

Lahore, Punjab Province, 54600, Pakistan

Location

University of the Witwatersrand Department of Radiat. Oncology

Johannesburg, Parktown, 2193, South Africa

Location

Mahidol University Faculty of Medicine Siriraj Hospital

Bangkok, Siriraj, 10700, Thailand

Location

Related Publications (4)

  • Sur RK, Donde B, Levin VC, Mannell A. Fractionated high dose rate intraluminal brachytherapy in palliation of advanced esophageal cancer. Int J Radiat Oncol Biol Phys. 1998 Jan 15;40(2):447-53. doi: 10.1016/s0360-3016(97)00710-4.

    PMID: 9457834BACKGROUND

  • Sur RK, Levin CV, Donde B, Sharma V, Miszczyk L, Nag S. Prospective randomized trial of HDR brachytherapy as a sole modality in palliation of advanced esophageal carcinoma--an International Atomic Energy Agency study. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):127-33. doi: 10.1016/s0360-3016(02)02702-5.

    PMID: 12007950BACKGROUND

  • Gaspar LE, Nag S, Herskovic A, Mantravadi R, Speiser B. American Brachytherapy Society (ABS) consensus guidelines for brachytherapy of esophageal cancer. Clinical Research Committee, American Brachytherapy Society, Philadelphia, PA. Int J Radiat Oncol Biol Phys. 1997 Apr 1;38(1):127-32. doi: 10.1016/s0360-3016(97)00231-9.

    PMID: 9212013BACKGROUND

  • Kumar MU, Swamy K, Supe SS, Anantha N. Influence of intraluminal brachytherapy dose on complications in the treatment of esophageal cancer. Int J Radiat Oncol Biol Phys. 1993 Dec 1;27(5):1069-72. doi: 10.1016/0360-3016(93)90525-z.

    PMID: 8262829BACKGROUND

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsDeglutition Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Eduardo Rosenblatt, MD

    International Atomic Energy Agency

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 23, 2008

Study Start

February 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

PA(1)IN(1)TH(1)CN(1)CR(1)ZA(1)CA(1)