Esophageal NeoplasmsNCT01151839
A Trial to Compare Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus
A study testing Esophagectomy and Neoadjuvant chemoradiation followed by surgery in people with Esophageal Neoplasms, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Esophagectomy and Neoadjuvant chemoradiation followed by surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Jul 2012
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age < 65 years
- Squamous cell carcinoma
- Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
- Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact <900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
- No evidence of distant metastasis on CECT.
Who cannot join
- Patient refused consent for the study
- Comorbid conditions which would preclude oesophagectomy
- Poor performance status (ECOG > 2)
- American Society of Anesthesiologists class IV
- Metastatic disease detected on evaluation
- Involvement of mediastinal structures except
- Carcinoma involving cervical esophagus
- Previous radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Nikhil, MS, 91-9654055630, drnkhl@gmail.com
Nikhil -, MS
About this study
Official title: Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial
Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.
- Conditions
- Esophageal Neoplasms
- Being tested
- Esophagectomy, Neoadjuvant chemoradiation followed by surgery
- Keywords
- Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagectomyProcedure or surgery
Patient with squamous cell carcinoma of esophagus will be treated with surgery alone
Neoadjuvant chemoradiation followed by surgeryProcedure or surgery
Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery Alone | Active comparator | Not described Receives: Procedure: Esophagectomy |
| Neoadjuvant chemoradiation followed by surgery | Active comparator | Not described Receives: Procedure: Neoadjuvant chemoradiation followed by surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resectability rate
To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
Measured: 2 years
postoperative morbidity
To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery
Measured: 2 Years
operative mortality
To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.
Measured: 2 Years
Secondary outcomes (2)
Early disease control
To compare the early disease control in patients randomized to receive either neoadjuvant chemoradiation and surgery or surgery alone.
Measured: 2 years
Treatment toxicity
This study will also assess the treatment toxicity of preoperative chemoradiation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Nikhil -, MS, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151839
- Sponsor's protocol ID
- IESC/T-186/2010
- Status last verified
- Jun 2010
- First submitted
- 25 Jun 2010
- Last updated
- 12 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Chemoradiation and Surgery Versus Surgery Alone in Squamous Cell Carcinoma of Oesophagus - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01151839
- Acronym / sponsor ID
- IESC/T-186/2010
- Conditions
- Esophageal Neoplasms
- Keywords
- Esophagus, squamous cell carcinoma, neoadjuvant chemoradiation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (estimated)
- First posted
- 29 Jun 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.
Carcinoma of the esophagus is the among the most common cancers in Indian population. While adenocarcinoma is more common in western countries, in India squamous cell carcinoma is the more frequent form. Surgery is the standard treatment in resectable lesions, but survival is poor. Adjuvant and neoadjuvant treatment therapy is used with an aim to improve the results. Though few randomized trials have addressed the issue of neoadjuvant chemoradiotherapy, the methodology was inhomogeneous and the populations studied were different. The investigators will be conducting a randomized controlled trial in patients with squamous cell carcinoma of the esophagus. Preoperative chemoradiation followed by surgery will be compared with surgery alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Alone | Active comparator | Procedure: Esophagectomy |
| Neoadjuvant chemoradiation followed by surgery | Active comparator | Procedure: Neoadjuvant chemoradiation followed by surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age < 65 years
- Squamous cell carcinoma
- Good performance status (Eastern Cooperative Oncology Group [ECOG] grades 0, 1 and 2)
- Contrast enhanced computerized tomographic (CECT) scan suggesting a potentially resectable lesion. The features of resectability assessed on CECT scan will include - no evidence of infiltration of mediastinal structures such as the aorta (angle of contact <900, no obliteration of the triangular fat space between the esophagus, aorta, and spine), and pericardium20, and no evidence of tracheobronchial fistula or tumor extension into the airway lumen.
- No evidence of distant metastasis on CECT.
Key exclusion criteria (8 listed)
- Patient refused consent for the study
- Comorbid conditions which would preclude oesophagectomy
- Metastatic disease detected on evaluation
- Involvement of mediastinal structures except
- Carcinoma involving cervical esophagus
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 |
|---|---|---|
| EsophagectomyPatient with squamous cell carcinoma of esophagus will be treated with surgery alone | Procedure or surgery | Surgery Alone |
| Neoadjuvant chemoradiation followed by surgeryPatient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery | Procedure or surgery | Neoadjuvant chemoradiation followed by surgery |
Primary outcome
Resectability rate
Time frame: 2 years
To compare the resectability rate of carcinoma esophagus between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery
postoperative morbidity
Time frame: 2 Years
To compare the postoperative morbidity between patients of carcinoma esophagus randomized to surgery alone versus chemoradiation followed by surgery
operative mortality
Time frame: 2 Years
To compare the operative mortality between patients randomized to surgery alone and neoadjuvant chemoradiation followed by surgery.
2 secondary outcomes
Early disease control
Time frame: 2 years
Treatment toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2010.
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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.
Nikhil -, MS principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy and Neoadjuvant chemoradiation followed by surgery in people with Esophageal Neoplasms, 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikhil -, MS (91-9654055630, drnkhl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resectability rate (time frame: 2 years). 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?
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 12 Jul 2010.