Gastric CancerPhase 2/3STOPEROPCHEMNCT01787539
The Role of Postoperative Cycles in the Perioperative Chemotherapy for Gastric Cancer
A Phase 2/3 study testing Postoperative Chemotherapy in people with Gastric Cancer, run by Medical University of Lublin at 2 sites in Poland.
Trial summary
Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Postoperative Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesPoland
- Study dates
- Feb 2013to Feb 2022
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histopathologically confirmed gastric cancer
- potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0. A clinical assessment of location, resectability and staging will be performed based on endoscopy, barium swallow, endoscopic ultrasound, multidetector computed tomography and diagnostic laparoscopy with cytology washing.
- medically fit to undergo a major abdominal surgery and in general condition allowing to tolerate long-lasting chemotherapy (Karnofsky Performance Status ≥70, ECOG 0-1)
Who cannot join
- Pregnancy or breast feeding.
- Diagnosed other malignancy and/or chemotherapy administrated within the last 5 years
- Gastric remnant cancer;
- Early Gastric Cancer;
- Irresectable or disseminated cancer with distant organ metastases and/or peritoneal spreading and/or positive cytology washing
- Poor performance status measured by Karnofsky index < 60 or ECOG < 1
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- Clinically important active systemic disease: unstable diabetes, circulatory failure of NYHA III or IV, unstable arterial hypertension, unstable coronary heart disease, recent heart infarct or brain insult within the last 6 months, severe COPD, peripheral neuropathy of grade 2-4;
- Severe hematological abnormalities: HGB < 10.0 gm/dL and/or neutropenia < 1500 /mm3; PLT < 100 000 /mm3.
- Severe renal dysfunction requiring peritoneal dialysis, hemodialysis or hemofiltration or oliguria <20ml/h.
- Severe liver dysfunction: acute or chronic hepatitis, liver cirrhosis, liver failure, abnormal liver testing: ALAT or ASPAT or ALP >2.5 - 5.0 × upper limit; total bilirubin >2 x upper limit.
- Concommitant infection
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
Lublin, Lublin Voivodeship, 20-081
Tomasz Skoczylas, MD, PhD, +48 81 5328810, tomskocz@yahoo.com
Grzegorz Wallner, Professor
- Recruiting
St. John's Cancer Center
Lublin, Lublin Voivodeship, 20-090
Tomasz Kubiatowski, MD, PhD, +48 81 7477511 ext. 129
Elżbieta Starosławska, MD, PhD
About this study
Official title: The Role of Postoperative Chemotherapy Cycles in the Combined Modality Therapy of Gastric Cancer With Perioperative Chemotherapy and Surgery in Pathological Responders
Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.
Read the detailed description
The MAGIC trial, also considered the "milestone" study, definitely proved that neoadjuvant chemotherapy improves the outcome of patients with locally advanced gastric cancer. Resection was considered curative in 79% under combination therapy versus in 69% of only operated patients (P = 0.02), 2-year survival rates were 50 and 41%, and 5-year-survival rates were 36 and 23% (P = 0.009), respectively. The substantial weak point of the MAGIC trial remains the fact that only about 40% of the patients received the full dosage of scheduled postoperative chemotherapy, mainly due to intolerance or toxicity reasons.
The noninferiority in relation to survival of capecitabine to 5-FU in triplet regimens for the treatment of patients with advanced esophagogastric cancer was demonstrated in the large multicenter randomized phase III, REAL-2 study, including 1002 patients. Capecitabine has overcome the doubts concerning the potential efficacy of oral drug administration in patients with gastric carcinoma, especially in relation to those patients who have undergone partial or total gastrectomy. The same study demonstrated the noninferiority of oxaliplatin versus cisplatin in advanced gastric cancer and confirmed the acceptable tolerability profile of this third-generation platinum analogue. It was anticipated that the use of these newer agents as components of triplet regimens would reduce toxicity and thereby render an alternative to the standard ECF combination easier to handle as a consequence of replacing the cisplatin component with oxaliplatin, replacing the infusional 5-fluorouracil component with oral capecitabine in EOX regimen. Furthermore, achieving a median overall survival time of 11.2 months, the EOX regimen appeared to be more active than ECF (median overall survival time, 9.9 months), with the higher 1-year survival rate 47% vs 38%, respectively. Compared with the ECF regimen, EOX was associated with significantly lower rates of grade 3 or 4 neutropenia and grade 2 alopecia, but significantly higher rates of grade 3 or 4 lethargy, diarrhea, and peripheral neuropathy. Based on the results of the REAL study, EOX is therefore tolerable, and at least as active as ECF. This modified regimen could therefore be considered to be a new standard treatment and may be an appropriate reference regimen for future studies in advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- Postoperative Chemotherapy
- Keywords
- gastric cancer, perioperative chemotherapy, combined modality therapy, gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative ChemotherapyDrug
Postoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks.
Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Complete Perioperative Chemotherapy | Experimental | Preoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks.
Surgery: total or subtotal gastrectomy with D2 lymph node dissection. The surgical resection will be conducted 4-6 weeks after preoperative chemotherapy.
Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery with the same regimen as in the preoperative part. Receives: Drug: Postoperative Chemotherapy |
| Preoperative Chemotherapy | No intervention | Preoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Surgery: total or subtotal gastrectomy with D2 lymph node dissection. The surgical resection will be conducted 4-6 weeks after preoperative chemotherapy. Patients with tumor regression grade 0, 1, 2 randomized to preoperative chemotherapy will not undergo postoperative chemotherapy and will be followed-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer free and overall survival
Measured: 5 years
Secondary outcomes (4)
overall and severe toxicity rate
Measured: 8 weeks
chemotherapy related mortality
Measured: 8 weeks
the rate of dose reduction for chemotherapeutics
Measured: 3 months
the rate of chemotherapy cessation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2022 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- St Johns' Oncology Center in Lublin
- Responsible party
- Principal investigator, Tomasz Skoczylas, Medical University of Lublin
- Investigators
- Tomasz Skoczylas, MD, PhD, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinGrzegorz Wallner, Professor, Principal investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of LublinElżbieta Starosławska, MD, PhD, Principal investigator, St Johns' Oncology Center in LublinTomasz Kubiatowski, MD, PhD, Principal investigator, St Johns' Oncology Center in Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787539
- Sponsor's protocol ID
- GC-COMB-0254/275/2012-MUL
- Other IDs
- GC-0254/282/2011/275/2012-MUL
- Acronym
- STOPEROPCHEM
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Postoperative Chemotherapy Cycles in the Combined Modality Therapy of Gastric Cancer With Perioperative Chemotherapy and Surgery in Pathological Responders
- ClinicalTrials.gov ID
- NCT01787539
- Acronym / sponsor ID
- STOPEROPCHEM / GC-COMB-0254/275/2012-MUL
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, perioperative chemotherapy, combined modality therapy, gastrectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- St Johns' Oncology Center in Lublin
- Study start
- Feb 2013
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 8 Feb 2013 (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.
Taking into account the substantial doubts concerning the potential benefit of postoperative part in the perioperative chemotherapy regimen we designed a study assessing value of this approach in gastric cancer. To improve compliance with a protocol regimen of this aggressive combined therapy we replaced tested in the MAGIC trial ECF regimen with more effective and better tolerable EOX chemotherapy regimen. The value of postoperative three-cycle EOX regimen will be tested in patients with locoregionally advanced gastric cancer with positive pathological response to preoperative three-cycle EOX chemotherapy regimen. The patients will be randomized to the postoperative chemotherapy or to the follow-up arm.
Detailed description
The MAGIC trial, also considered the "milestone" study, definitely proved that neoadjuvant chemotherapy improves the outcome of patients with locally advanced gastric cancer. Resection was considered curative in 79% under combination therapy versus in 69% of only operated patients (P = 0.02), 2-year survival rates were 50 and 41%, and 5-year-survival rates were 36 and 23% (P = 0.009), respectively. The substantial weak point of the MAGIC trial remains the fact that only about 40% of the patients received the full dosage of scheduled postoperative chemotherapy, mainly due to intolerance or toxicity reasons.
The noninferiority in relation to survival of capecitabine to 5-FU in triplet regimens for the treatment of patients with advanced esophagogastric cancer was demonstrated in the large multicenter randomized phase III, REAL-2 study, including 1002 patients. Capecitabine has overcome the doubts concerning the potential efficacy of oral drug administration in patients with gastric carcinoma, especially in relation to those patients who have undergone partial or total gastrectomy. The same study demonstrated the noninferiority of oxaliplatin versus cisplatin in advanced gastric cancer and confirmed the acceptable tolerability profile of this third-generation platinum analogue. It was anticipated that the use of these newer agents as components of triplet regimens would reduce toxicity and thereby render an alternative to the standard ECF combination easier to handle as a consequence of replacing the cisplatin component with oxaliplatin, replacing the infusional 5-fluorouracil component with oral capecitabine in EOX regimen. Furthermore, achieving a median overall survival time of 11.2 months, the EOX regimen appeared to be more active than ECF (median overall survival time, 9.9 months), with the higher 1-year survival rate 47% vs 38%, respectively. Compared with the ECF regimen, EOX was associated with significantly lower rates of grade 3 or 4 neutropenia and grade 2 alopecia, but significantly higher rates of grade 3 or 4 lethargy, diarrhea, and peripheral neuropathy. Based on the results of the REAL study, EOX is therefore tolerable, and at least as active as ECF. This modified regimen could therefore be considered to be a new standard treatment and may be an appropriate reference regimen for future studies in advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Perioperative Chemotherapy | Experimental | Drug: Postoperative ChemotherapyPreoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Surgery: total or subtotal gastrectomy with D2 lymph node dissection. The surgical resection will be conducted 4-6 weeks after preoperative chemotherapy. Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery with the same regimen as in the preoperative part. |
| Preoperative Chemotherapy | No intervention | –Preoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Surgery: total or subtotal gastrectomy with D2 lymph node dissection. The surgical resection will be conducted 4-6 weeks after preoperative chemotherapy. Patients with tumor regression grade 0, 1, 2 randomized to preoperative chemotherapy will not undergo postoperative chemotherapy and will be followed-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- histopathologically confirmed gastric cancer
- potentially resectable, local or locoregional cancer with clinical staging cT2-4aN0-3M0. A clinical assessment of location, resectability and staging will be performed based on endoscopy, barium swallow, endoscopic ultrasound, multidetector computed tomography and diagnostic laparoscopy with cytology washing.
- medically fit to undergo a major abdominal surgery and in general condition allowing to tolerate long-lasting chemotherapy (Karnofsky Performance Status ≥70, ECOG 0-1)
Key exclusion criteria (11 listed)
- Pregnancy or breast feeding.
- Diagnosed other malignancy and/or chemotherapy administrated within the last 5 years
- Gastric remnant cancer;
- Early Gastric Cancer;
- Irresectable or disseminated cancer with distant organ metastases and/or peritoneal spreading and/or positive cytology washing
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 |
|---|---|---|
| Postoperative ChemotherapyPostoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks. Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery. | Drug | Complete Perioperative Chemotherapy |
Primary outcome
cancer free and overall survival
Time frame: 5 years
4 secondary outcomes
overall and severe toxicity rate
Time frame: 8 weeks
chemotherapy related mortality
Time frame: 8 weeks
the rate of dose reduction for chemotherapeutics
Time frame: 3 months
the rate of chemotherapy cessation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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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.
Tomasz Skoczylas, MD, PhD principal investigator
Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
Grzegorz Wallner, Professor principal investigator
Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
Elżbieta Starosławska, MD, PhD principal investigator
St Johns' Oncology Center in Lublin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Postoperative Chemotherapy in people with Gastric Cancer, run by Medical University of Lublin at 2 sites in Poland.
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 3 inclusion and 11 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Skoczylas, MD, PhD (+48 81 5328810, tomskocz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer free and overall survival (time frame: 5 years). 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 8 Feb 2013.