Esophageal CancerPhase 3NCT00665197
Palliative Radiotherapy and Brachytherapy for Oesophageal Cancer Dysphagia
A Phase 3 study testing Protracted Course Radiotherapy and Short Course Radiotherapy in people with Esophageal Cancer, run by International Atomic Energy Agency at 7 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Protracted Course Radiotherapy and Short Course Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Feb 2007to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Canada1 site
Credit Valley Hospital Statistical Centre
Credit Valley, Ontario, L5M 2N1
China1 site
Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Croatia1 site
University of Zagreb Clinical Hospital
Zagreb, City of Zagreb, 10000
Pakistan1 site
Institute of Nuclear Medicine and Oncology
Lahore, Punjab Province, 54600
South Africa1 site
University of the Witwatersrand Department of Radiat. Oncology
Johannesburg, Parktown, 2193
Thailand1 site
Mahidol University Faculty of Medicine Siriraj Hospital
Bangkok, Siriraj, 10700
About this study
Official title: Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.
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).
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Protracted Course Radiotherapy, Short Course Radiotherapy
- Keywords
- Esophageal cancer, Brachytherapy, Radiotherapy, Palliation, Dysphagia
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protracted Course RadiotherapyRadiation
External Beam Radiation 30 Gy in 10 fractions
Short Course RadiotherapyRadiation
External Beam Radiation 20 Gy in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Radiation: Short Course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia relief
Measured: 3 years
Secondary outcomes (2)
Quality of life
Measured: 3 years
Treatment Toxicity
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Atomic Energy Agency
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eduardo Rosenblatt, MD, Study chair, International Atomic Energy Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665197
- Sponsor's protocol ID
- E3.30.27
- Status last verified
- Oct 2011
- First submitted
- 18 Apr 2008
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9457834Sur 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.
PubMed 12007950Gaspar 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.
PubMed 9212013Kumar 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.
PubMed 8262829
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Radiotherapy Using New Strategies of Treatment Delivery With Focus on Oesophageal Cancer.
- ClinicalTrials.gov ID
- NCT00665197
- Acronym / sponsor ID
- E3.30.27
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Brachytherapy, Radiotherapy, Palliation, Dysphagia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- International Atomic Energy AgencyOther government
- Study start
- Feb 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protracted Course Radiotherapy | Active comparator | Radiation: Protracted Course RadiotherapyHigh Dose Rate brachytherapy 8.0 Gy x 2 External beam radiotherapy 30 Gy in 10 fractions of 3.0 Gy |
| Short Course Radiotherapy | Experimental | Radiation: Short Course RadiotherapyHigh Dose Rate brachytherapy 8.0 Gy x 2 External beam radiotherapy 20 Gy in 5 fractions of 4.0 Gy |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protracted Course RadiotherapyExternal Beam Radiation 30 Gy in 10 fractions | Radiation | Protracted Course Radiotherapy |
| Short Course RadiotherapyExternal Beam Radiation 20 Gy in 5 fractions | Radiation | Short Course Radiotherapy |
Primary outcome
Dysphagia relief
Time frame: 3 years
2 secondary outcomes
Quality of life
Time frame: 3 years
Treatment Toxicity
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
- Background: PubMed 9457834Sur 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.
- Background: PubMed 12007950Sur 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.
- Background: PubMed 9212013Gaspar 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.
- Background: PubMed 8262829Kumar 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.
- IAEA websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Rosenblatt, MD study chair
International Atomic Energy Agency
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Protracted Course Radiotherapy and Short Course Radiotherapy in people with Esophageal Cancer, run by International Atomic Energy Agency at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, China, Croatia, India, Pakistan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia relief (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00665197, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2011.