Gastric CancerNCT00447746
A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial
A study testing D1 or D2 lymphadenectomy for gastric cancer patients in people with Gastric Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- D1 or D2 lymphadenectomy for gastric cancer patients
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Mar 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Staging investigations or intraoperative exploration indicating inoperable disease
- Patients medically unfit for major surgery
- Patients who have been given preoperative chemotherapy/chemoradiation.
- Patients with gastroesophageal junction tumours
- Patients unreliable for follow up
- Patients above the age of 70 years
- Past history of malignancy
Trial locations and contacts
1 site in 1 country.
Dr Shailesh v Shrikhande, M.S. contact
India1 site
Tata Memorial Hospital,Tata Memorial Centre
Mumbai, Maharashtra, 400012
Dr K M Mohandas, M.D.
About this study
Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible.
However the results of surgery are generally disapointing in most large series.The exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.The extent of surgery and particularly the development of systematic lymphadenectomy(D2)has been credited in Japan for the improved outcome in patients with gastric cancer.
Read more
Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken.
In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament.
Currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.Neither is any of these procedures experimental.
We are doing this trial to see whether one of these procedures is superior to the other.
- Conditions
- Gastric Cancer
- Being tested
- D1 or D2 lymphadenectomy for gastric cancer patients
- Keywords
- Comparison between D1 and D2 lymphadenectomy for gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D1 or D2 lymphadenectomy for gastric cancer patientsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
5 year overall survival
Secondary outcomes (3)
: 5 year disease free survival
: 5 year local recurrence
: Postoperative morbidity and mortality rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMar 2007
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Dr Parul J Shukla, M.S.,FRCS, Principal investigator, Tata Memorial Centre,Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447746
- Sponsor's protocol ID
- TMH 262
- Status last verified
- Mar 2007
- First submitted
- 14 Mar 2007
- Last updated
- 15 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between D1 and D2 Lymphadenectomy in Gastric Cancer : A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00447746
- Acronym / sponsor ID
- TMH 262
- Conditions
- Gastric Cancer
- Keywords
- Comparison between D1 and D2 lymphadenectomy for gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Mar 2007
- Study completion
- Mar 2014
- First posted
- 15 Mar 2007 (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.
Gastric cancer remains the second most common cancer worldwide.Although the prognosis is poor for majority of patients , long term survival is achievable in patients in whom surgical resection is possible.
However the results of surgery are generally disapointing in most large series.The exception to this appears to be Japan and far east where a standardized approach to surgery is undertaken with low morbidity and mortality.The extent of surgery and particularly the development of systematic lymphadenectomy(D2)has been credited in Japan for the improved outcome in patients with gastric cancer.
Hence for comparing the difference between D1 and D2 lymphadenectomy for gastric cancer in terms of overall survival,disease free survival and loco regional recurrence and also post operative morbidity and mortality following both these procedures,this study has been undertaken.
In D1 lymphadenectomy, only those lymph nodes which are adjacent to the part of stomach being resected will be removed.In D2 lymphadenectomy other lymph nodes draining the stomach will also be removed according to internationally accepted guidelines and also include resection of greater omentum along with anterior layer of transverse mesocolon and lesser omentum upto its attachment to hepatoduodenal ligament.
Currently both these procedures are widely practised worldwide and there is no definite evidence showing the superiority of one procedure over the other.Neither is any of these procedures experimental.
We are doing this trial to see whether one of these procedures is superior to the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Staging investigations or intraoperative exploration indicating inoperable disease
- Patients medically unfit for major surgery
- Patients who have been given preoperative chemotherapy/chemoradiation.
- Patients with gastroesophageal junction tumours
- Patients unreliable for follow up
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 |
|---|---|---|
| D1 or D2 lymphadenectomy for gastric cancer patients | Procedure or surgery | – |
Primary outcome
5 year overall survival
3 secondary outcomes
: 5 year disease free survival
: 5 year local recurrence
: Postoperative morbidity and mortality rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2007.
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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.
Dr Shailesh v Shrikhande, M.S. contact
Dr Parul J Shukla, M.S.,FRCS principal investigator
Tata Memorial Centre,Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D1 or D2 lymphadenectomy for gastric cancer patients in people with Gastric Cancer, run by Tata Memorial Hospital 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 0 inclusion and 7 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 15 Mar 2007. 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 Dr Parul J Shukla, M.S.,FRCS (+912224177172, pjshukla@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 year overall survival. 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 15 Mar 2007.