Stomach NeoplasmsPhase 2NCT00420394
Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer
A Phase 2 study testing Chemotherapy, surgery and radiotherapy in people with Stomach Neoplasms, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Chemotherapy, surgery and radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to not given
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
- T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
- Disease must be clinically limited to the stomach or GEJ.
- Pre-treatment Port-a-Cath insertion obligatory
- No prior chemotherapy.
- No prior radiotherapy.
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- Patients must be surgical candidates as determined by the treating surgeon.
- Adequate organ function defined as:
- Patients must have an ECOG Performance Status < 1.
- Patients must be able to sign the informed consent document.
Who cannot join
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- Patients with primary carcinomas of the esophagus.
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- Patients with evidence of metastatic disease are not eligible.
- New York Heart Association Class III or IV heart disease.
- Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.
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- Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.
- Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).
- Clinically significant hearing loss.
- Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
- Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center,Oncology Center
Beersheba
margarita Tokar, MD, +972-86400768, ritato@clalit.org.il
Konstantin Lavrenkov, MD
About this study
Official title: Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer
Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.
Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer
- Conditions
- Stomach Neoplasms
- Being tested
- Chemotherapy, surgery, radiotherapy
- Keywords
- Neoadjuvant chemotherapy, Adjuvant chemoradiotherapy, Adenocarcinoma of stomach and gastroesophageal junction
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyProcedure or surgery
surgeryProcedure or surgery
radiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the study regimen.
Secondary outcomes (3)
Rate of R0 resection following chemotherapy.
Morbidity and mortality of surgery following chemotherapy.
Overall and progression free survival following the study treatment plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Margarita Tokar, MD, Study chair, Soroka University Medical Center and Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420394
- Sponsor's protocol ID
- SOR446006ctil
- Status last verified
- Jan 2007
- First submitted
- 9 Jan 2007
- Last updated
- 20 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer
- ClinicalTrials.gov ID
- NCT00420394
- Acronym / sponsor ID
- SOR446006ctil
- Conditions
- Stomach Neoplasms
- Keywords
- Neoadjuvant chemotherapy, Adjuvant chemoradiotherapy, Adenocarcinoma of stomach and gastroesophageal junction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- First posted
- 11 Jan 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.
Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.
Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.
- T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3
- Disease must be clinically limited to the stomach or GEJ.
- Pre-treatment Port-a-Cath insertion obligatory
- No prior chemotherapy.
Key exclusion criteria (12 listed)
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- Patients with primary carcinomas of the esophagus.
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- Patients with evidence of metastatic disease are not eligible.
- New York Heart Association Class III or IV heart disease.
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 |
|---|---|---|
| Chemotherapy | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
| radiotherapy | Procedure or surgery | – |
Primary outcome
Feasibility of the study regimen.
3 secondary outcomes
Rate of R0 resection following chemotherapy.
Morbidity and mortality of surgery following chemotherapy.
Overall and progression free survival following the study treatment plan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
Margarita Tokar, MD study chair
Soroka University Medical Center and Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy, surgery and radiotherapy in people with Stomach Neoplasms, run by Soroka University Medical Center at 1 site in Israel.
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 10 inclusion and 12 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 20 Jun 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Margarita Tokar, MD (+972-8-6400768, Ritato@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study regimen.. 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 20 Jun 2007.