Gastric NeoplasmPhase 3NCT00149266
Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
A Phase 3 study testing Surgery: abdominal and transhiatal approach and Surgery: left thoraco-abdominal approach in people with Gastric Neoplasm, run by Japan Clinical Oncology Group at 1 site in Japan.
Trial summary
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Gastric Neoplasm
- What is being tested?
- Surgery: abdominal and transhiatal approach and Surgery: left thoraco-abdominal approach
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- 1 siteJapan
- Study dates
- Jul 1995to Dec 2008
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- histologically proven adenocarcinoma
- 75 years old or younger
- forced expiratory volume in one second ≥ 50 %
- arterial oxygen pressure in room air ≥ 70 mmHg
- clinically T2/T3/T4 with ≤3 cm esophageal invasion
- written consent
Who cannot join
- Carcinoma in the remnant stomach
- Borrmann type 4 (linitis plastica)
- synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
- history of left thoracotomy, or left pleural adhesion
- past history of myocardial infarction or positive results of exercise ECG
- liver cirrhosis, or chronic liver disease with indocyanine green test ≥15%
Trial locations and contacts
1 site in 1 country.
Japan1 site
National Cancer Center Hospital
5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045
About this study
To compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer
Read the detailed description
For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.
- Conditions
- Gastric Neoplasm
- Being tested
- Surgery: abdominal and transhiatal approach, Surgery: left thoraco-abdominal approach
- Keywords
- stomach neoplasms, lymph node resection, cardia, thoracotomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery: abdominal and transhiatal approachProcedure or surgery
Surgery: left thoraco-abdominal approachProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Secondary outcomes (3)
relapse-free survival
operative morbidity and mortality
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 1995
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric NeoplasmStudies 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Mitsuru Sasako, MD, Study chair, Gastric Surgery Division, National Cancer Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149266
- Sponsor's protocol ID
- JCOG9502
- Other IDs
- C000000122
- Status last verified
- Feb 2009
- First submitted
- 7 Sep 2005
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sasako M, Sano T, Yamamoto S, Sairenji M, Arai K, Kinoshita T, Nashimoto A, Hiratsuka M; Japan Clinical Oncology Group (JCOG9502). Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial. Lancet Oncol. 2006 Aug;7(8):644-51. doi: 10.1016/S1470-2045(06)70766-5.
PubMed 16887481Kurokawa Y, Sasako M, Sano T, Yoshikawa T, Iwasaki Y, Nashimoto A, Ito S, Kurita A, Mizusawa J, Nakamura K; Japan Clinical Oncology Group (JCOG9502). Ten-year follow-up results of a randomized clinical trial comparing left thoracoabdominal and abdominal transhiatal approaches to total gastrectomy for adenocarcinoma of the oesophagogastric junction or gastric cardia. Br J Surg. 2015 Mar;102(4):341-8. doi: 10.1002/bjs.9764. Epub 2015 Jan 21.
PubMed 25605628Kurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45. doi: 10.1002/bjs.7297.
PubMed 21104822
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Surgical Approaches to Gastric Cancer Invading the Esophagus (JCOG9502)
- ClinicalTrials.gov ID
- NCT00149266
- Acronym / sponsor ID
- JCOG9502
- Conditions
- Gastric Neoplasm
- Keywords
- stomach neoplasms, lymph node resection, cardia, thoracotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jul 1995
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 2005 (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 compare left thoraco-abdominal approach with abdominal and transhiatal approach to cardia or subcardia cancer
Detailed description
For gastric cancers with esophageal invasion (Siewert type II and III), thoraco-abdominal approach has shown better survival results than abdominal approach in retrospective analyses. However, patients having mediastinal nodal metastasis have poor prognosis and the benefit of thoraco-abdominal approach is still controversial. We evaluated the two approaches in a prospective randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- histologically proven adenocarcinoma
- 75 years old or younger
- forced expiratory volume in one second ≥ 50 %
- arterial oxygen pressure in room air ≥ 70 mmHg
- clinically T2/T3/T4 with ≤3 cm esophageal invasion
Key exclusion criteria (6 listed)
- Carcinoma in the remnant stomach
- Borrmann type 4 (linitis plastica)
- synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
- history of left thoracotomy, or left pleural adhesion
- past history of myocardial infarction or positive results of exercise ECG
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 |
|---|---|---|
| Surgery: abdominal and transhiatal approach | Procedure or surgery | – |
| Surgery: left thoraco-abdominal approach | Procedure or surgery | – |
Primary outcome
overall survival
3 secondary outcomes
relapse-free survival
operative morbidity and mortality
quality of life
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
- Results publication: PubMed 16887481Sasako M, Sano T, Yamamoto S, Sairenji M, Arai K, Kinoshita T, Nashimoto A, Hiratsuka M; Japan Clinical Oncology Group (JCOG9502). Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial. Lancet Oncol. 2006 Aug;7(8):644-51. doi: 10.1016/S1470-2045(06)70766-5.
- Derived from this study: PubMed 25605628Kurokawa Y, Sasako M, Sano T, Yoshikawa T, Iwasaki Y, Nashimoto A, Ito S, Kurita A, Mizusawa J, Nakamura K; Japan Clinical Oncology Group (JCOG9502). Ten-year follow-up results of a randomized clinical trial comparing left thoracoabdominal and abdominal transhiatal approaches to total gastrectomy for adenocarcinoma of the oesophagogastric junction or gastric cardia. Br J Surg. 2015 Mar;102(4):341-8. doi: 10.1002/bjs.9764. Epub 2015 Jan 21.
- Derived from this study: PubMed 21104822Kurokawa Y, Sasako M, Sano T, Shibata T, Ito S, Nashimoto A, Kurita A, Kinoshita T; Japan Clinical Oncology Group. Functional outcomes after extended surgery for gastric cancer. Br J Surg. 2011 Feb;98(2):239-45. doi: 10.1002/bjs.7297.
- Related InfoLink 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.
Mitsuru Sasako, MD study chair
Gastric Surgery Division, National Cancer Center Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery: abdominal and transhiatal approach and Surgery: left thoraco-abdominal approach in people with Gastric Neoplasm, run by Japan Clinical Oncology Group at 1 site in Japan.
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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Feb 2009. 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 Japan. 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 was stopped early. Results are not available in the source record.
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?
overall survival. 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 NCT00149266, which also lists 3 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 3 Feb 2009.