Oesophageal CancerNCT01179074
Role of Radiotherapy Following Oesophageal Stenting in Cancer
A study testing oesophageal stenting with self expandable metal stent and Oesophageal stent followed by external beam radiotherapy in people with Oesophageal Cancer, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Cancer
- What is being tested?
- oesophageal stenting with self expandable metal stent and Oesophageal stent followed by external beam radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2007to Mar 2009
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
- Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.
Who cannot join
- Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded
Trial locations and contacts
1 site in 1 country.
India1 site
Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial
To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer
Read the detailed description
A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia.
STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.
PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.
- Conditions
- Oesophageal Cancer
- Being tested
- oesophageal stenting with self expandable metal stent, Oesophageal stent followed by external beam radiotherapy
- Keywords
- palliation inoperable oesophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oesophageal stenting with self expandable metal stentProcedure or surgery
Also called Ultraflex stent, Microvasive, Boston Scientific
oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
Oesophageal stent followed by external beam radiotherapyProcedure or surgery
Also called External beam radiotherapy
30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
| Study group | Role | What they receive |
|---|---|---|
| Oesophageal stent alone | Active comparator | Patients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents Receives: Procedure: oesophageal stenting with self expandable metal stent |
| Oesophageal stent followed by EBRT | Active comparator | Patients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks) Receives: Procedure: oesophageal stenting with self expandable metal stent; Procedure: Oesophageal stent followed by external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of dysphagia
Relief of dysphagia will be assessed by stratifying the ability to swallow into the following grades.
Grade 1: Difficulty in swallowing solid food Grade 2: Difficulty in swallowing semisolid food Grade 3: Difficulty in swallowing liquids Grade 4: Difficulty in swallowing even saliva The dysphagia scores will be assessed 1 week after intervention (stenting and radiotherapy)in the two groups
Measured: 1 week after intervention
Relief of dysphagia
Dysphagia grades at 3 months will be assessed in the two groups
Measured: 3 months following intervention
Relief of dysphagia
Dysphagia grades at 5 months will be assessed in the two groups
Measured: 5 months after intervention
Secondary outcomes (1)
Survival
Patients will be followed up at baseline, 1 week after oesophageal stenting, 1 week after completion of radiotherapy and 2 monthly thereafter till their death
Measured: From the date of diagnosis till death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startApr 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oesophageal 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Tushar K Chattopadhyay, MS, Study director, Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179074
- Sponsor's protocol ID
- SEMSRT-1
- Status last verified
- Feb 2010
- First submitted
- 25 May 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7.
PubMed 7694321
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial
- ClinicalTrials.gov ID
- NCT01179074
- Acronym / sponsor ID
- SEMSRT-1
- Conditions
- Oesophageal Cancer
- Keywords
- palliation inoperable oesophageal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 11 Aug 2010 (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.
To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer
Detailed description
A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia.
STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.
PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oesophageal stent alone | Active comparator | Procedure: oesophageal stenting with self expandable metal stentPatients of inoperable oesophageal cancer in this arm underwent oesophageal stenting with self expandable metal stents |
| Oesophageal stent followed by EBRT | Active comparator | Procedure: oesophageal stenting with self expandable metal stent, Procedure: Oesophageal stent followed by external beam radiotherapyPatients in this arm underwent oesophageal stenting with self expandable metal stents followed by external beam radiotherapy (30Gy/10#/2weeks) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
- Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.
Key exclusion criteria (1 listed)
- Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded
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 |
|---|---|---|
| oesophageal stenting with self expandable metal stentAlso: Ultraflex stent, Microvasive, Boston Scientificoesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer | Procedure or surgery | Oesophageal stent alone, Oesophageal stent followed by EBRT |
| Oesophageal stent followed by external beam radiotherapyAlso: External beam radiotherapy30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group | Procedure or surgery | Oesophageal stent followed by EBRT |
Primary outcome
Relief of dysphagia
Time frame: 1 week after intervention
Relief of dysphagia will be assessed by stratifying the ability to swallow into the following grades. Grade 1: Difficulty in swallowing solid food Grade 2: Difficulty in swallowing semisolid food Grade 3: Difficulty in swallowing liquids Grade 4: Difficulty in swallowing even saliva The dysphagia scores will be assessed 1 week after intervention (stenting and radiotherapy)in the two groups
Relief of dysphagia
Time frame: 3 months following intervention
Dysphagia grades at 3 months will be assessed in the two groups
Relief of dysphagia
Time frame: 5 months after intervention
Dysphagia grades at 5 months will be assessed in the two groups
1 secondary outcome
Survival
Time frame: From the date of diagnosis till death
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 11 Aug 2010.
- Background: PubMed 7694321Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7.
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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.
Tushar K Chattopadhyay, MS study director
Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oesophageal stenting with self expandable metal stent and Oesophageal stent followed by external beam radiotherapy in people with Oesophageal Cancer, run by All India Institute of Medical Sciences at 1 site in India.
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 2 inclusion and 1 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 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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.
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?
Relief of dysphagia (time frame: 1 week after intervention). The study lists 3 primary outcomes in all. 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 NCT01179074, which also lists 1 linked publication.
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 11 Aug 2010.