Gastric CancerNCT01381913
Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
An observational study of Gastric Cancer and Chemoradiation, run by Kagawa University at 1 site in Japan.
Trial summary
Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer, Chemoradiation
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2005to May 2011
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Histologically proven gastric adenocarcinoma * Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
Who may be able to join
- Histologically proven gastric adenocarcinoma
- Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
- No metastases outside of Group 2 lymph nodes
- Neither peritoneal metastasis nor liver metastasis
- No other distant metastasis
- An Eastern cooperative oncology group performance status of between 0 and 2
- No prior radiation therapy
- Sufficient organ function
Who cannot join
- A synchronous or previously active malignancy
- Insufficient oral intake
- A history of severe allergy
- Watery diarrhea
- Severe co-morbidities
- Requiring therapy for pericardial effusion or pleural effusion
- Contraindications to S-1 or radiotherapy.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
Kita, Kagawa-ken, 761-0793
About this study
Official title: Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion
Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.
Read the detailed description
Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.
On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.
- Conditions
- Gastric Cancer, Chemoradiation
- Keywords
- Gastric cancer, Chemoradiotherapy, Adjacent tissue invasion, Feasibility trial
- Medical subject headings
- Stomach Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionMay 2011
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kagawa University
- Sponsor type
- University, hospital or other
- Investigators
- Shinichi Yachida, M. D. Ph. D., Study director, Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, JapanYasuyuki Suzuki, M. D. Ph. D., Principal investigator, Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381913
- Sponsor's protocol ID
- NACRT-GC
- Status last verified
- Oct 2005
- First submitted
- 22 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion
- ClinicalTrials.gov ID
- NCT01381913
- Acronym / sponsor ID
- NACRT-GC
- Conditions
- Gastric Cancer, Chemoradiation
- Keywords
- Gastric cancer, Chemoradiotherapy, Adjacent tissue invasion, Feasibility trial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Kagawa UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 27 Jun 2011 (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.
Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.
Detailed description
Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.
On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Histologically proven gastric adenocarcinoma * Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
Key inclusion criteria (8 listed)
- Histologically proven gastric adenocarcinoma
- Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
- No metastases outside of Group 2 lymph nodes
- Neither peritoneal metastasis nor liver metastasis
- No other distant metastasis
Key exclusion criteria (7 listed)
- A synchronous or previously active malignancy
- Insufficient oral intake
- A history of severe allergy
- Watery diarrhea
- Severe co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 27 Jun 2011.
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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.
Shinichi Yachida, M. D. Ph. D. study director
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
Yasuyuki Suzuki, M. D. Ph. D. principal investigator
Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Chemoradiation, run by Kagawa University 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 8 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: finished, as of the sponsor's last update on 27 Jun 2011. 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.
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.
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 27 Jun 2011.