Gastric CancerPhase 2/3NCT02442362
TOF Versus SOX in Metastatic Gastric Cancer
A Phase 2/3 study testing paclitaxel+oxaliplatin+fluorouracil and oxaliplatin+S1 in people with Gastric Cancer, run by The First People's Hospital of Changzhou.
Trial summary
This study was designed to compare the efficacy and safety of aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for metastatic gastric cancer (GC) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- paclitaxel+oxaliplatin+fluorouracil and oxaliplatin+S1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed mGC (stage IV)
- ages between 20 and 80 years
- measurable or assessable lesions by imaging studies according to the RECIST guideline 21
- no prior chemotherapy except for postoperative adjuvant chemotherapy for more than 12 months before entry into the study
- Eastern Cooperative Oncology Group (ECOG) performance status score less than 3
- hepatic function
Show all 11Show fewer
- total bilirubin ≤ 1.5 × the institutional upper limit of normal value, aspartate aminotransferase/alanine aminotransferase ≤ 2.5 × the institutional upper limit of normal value, and alkaline phosphatase ≤ 2.5 × the institutional upper limit of normal value
- renal function (serum creatinine level ≤ 1.5 mg/dL and creatinine clearance ≥ 50 ml/min)
- adequate bone marrow function (hemoglobin level ≥ 90 g/L, white blood cell count of 4-10×109/L, neutrophil count ≥ 2×109/L, and platelet count ≥ 100×109/L)
- estimated life expectancy more than 3 months
- no other secondary malignant tumors.
Who cannot join
- preexisted peripheral toxicity ≥ grade 2 of the National Cancer Institute Common Toxicity Criteria
- concurrent or prior malignancy
- central nervous system metastases
- concurrent treatment that interfered with the study evaluation
- active infection
- other uncontrolled underlying medical conditions that would impair the ability of the patients to receive the planned treatment
- having inadequate calorie and fluid intake
- pregnant, and breastfeeding women or women of child-bearing potential without adequate contraception.
About this study
Official title: Paclitaxel/Oxaliplatin/Fluorouracil (TOF) Regimen Versus S-1/Oxaliplatin (SOX) Regimen Metastatic Gastric Cancer Patients
This study was designed to compare the efficacy and safety of aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for metastatic gastric cancer (GC) patients.
Read the detailed description
Gastric carcinoma ranks second among the most common causes of cancer deaths worldwide, with especial high prevalence in Asia . Gastric cancer is the third most common cancer in China and the incidence rate and death rate of gastric cancer in Jiangsu Province are especially higher than the national average. Surgical resection is the preferred treatment for gastric cancer, but approximately two-thirds of patients have metastatic disease at the time of diagnosis. Prognosis in these patients is poor, with a median survival time of 3 to 5 months without treatment and a reported 5-year survival rate of 9.4%. Even receiving curative gastrectomy, 60% of mGC patients develop local recurrences or distant metastasis.
For advanced-stage patients with inoperable gastric tumors, chemotherapy is considered the most effective treatment option and the efficacy of postoperative chemotherapy has been acknowledged. However, a worldwide consensus on standard chemotherapy regimens has yet to be established. The prognosis has gradually improved because of advances in chemotherapy regimens, but is not yet satisfactory.Among various regimens, the combinations of paclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen have become two important ones.
Paclitaxel can bind to microtubules and induces hyperstabilization leading to cell cycle arrest and apoptosis. The response rate of GC patients to paclitaxel is 20%-25%. Oxaliplatin is a third-generation diaminocyclohexane platinum compound which has a wide range of antitumor activities, appearing to have a better safety profile than cisplatin. The response rate of mGC patients to FOLFOX-4 regimen is 38%-43%. S-1 is an oral anti-cancer agent composed of tegafur, 5-chloro-2,4-dihydroxypyridine, and oteracil potassium. The applying of S-1 as adjuvant chemotherapy for mGC can improve the overall survival (OS) and relapse-free survival. A meta-analysis showed OS favored S-1-based chemotherapy over 5-FU-based chemotherapy in mGC. S-1 plus oxaliplatin (SOX) have showed non-inferiority to S-1 plus cisplatin in PFS and that the treatment was well tolerated in patients with mGC.
No study is available comparing the efficacy and safety of TOF and SOX regimens. So the investigators performed the present randomized, controlled study to compare the efficacy and safety of the two regimens in mGC patients.
- Conditions
- Gastric Cancer
- Being tested
- paclitaxel+oxaliplatin+fluorouracil, oxaliplatin+S1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel+oxaliplatin+fluorouracilDrug
Also called TOF regimen
Patients treated with "paclitaxel+oxaliplatin+fluorouracil": paclitaxel (135 mg/m2 iv) on day 1, oxaliplatin (100 mg/m2 iv) on day 1, fluorouracil (500 mg/m2 continuous iv) on day 1-5twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14.
oxaliplatin+S1Drug
Also called SOX regimen
Patients treated with "oxaliplatin+S1": oxaliplatin (130 mg/m2 iv) on day 1 and S-1 (40 mg twice/day for body surface area < 1.25 m2 and 60 mg twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14
| Study group | Role | What they receive |
|---|---|---|
| TOF Group | Active comparator | Patients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil" Receives: Drug: paclitaxel+oxaliplatin+fluorouracil |
| SOX Group | Experimental | The patients in the SOX group received chemotherapy with 'oxaliplatin+S1' Receives: Drug: oxaliplatin+S1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor respone
According to the RECIST guideline
Measured: 8 weeks
Secondary outcomes (1)
Side-effect
Safety was evaluated according to the NCI-CTC
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJun 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liangrong Shi, The First People's Hospital of Changzhou
- Investigators
- Changping Wu, M.D., Study director, the First People' Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442362
- Sponsor's protocol ID
- CZ-GA-001
- Status last verified
- May 2015
- First submitted
- 10 May 2015
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel/Oxaliplatin/Fluorouracil (TOF) Regimen Versus S-1/Oxaliplatin (SOX) Regimen Metastatic Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT02442362
- Acronym / sponsor ID
- CZ-GA-001
- Conditions
- Gastric Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 May 2015 (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.
This study was designed to compare the efficacy and safety of aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for metastatic gastric cancer (GC) patients.
Detailed description
Gastric carcinoma ranks second among the most common causes of cancer deaths worldwide, with especial high prevalence in Asia . Gastric cancer is the third most common cancer in China and the incidence rate and death rate of gastric cancer in Jiangsu Province are especially higher than the national average. Surgical resection is the preferred treatment for gastric cancer, but approximately two-thirds of patients have metastatic disease at the time of diagnosis. Prognosis in these patients is poor, with a median survival time of 3 to 5 months without treatment and a reported 5-year survival rate of 9.4%. Even receiving curative gastrectomy, 60% of mGC patients develop local recurrences or distant metastasis.
For advanced-stage patients with inoperable gastric tumors, chemotherapy is considered the most effective treatment option and the efficacy of postoperative chemotherapy has been acknowledged. However, a worldwide consensus on standard chemotherapy regimens has yet to be established. The prognosis has gradually improved because of advances in chemotherapy regimens, but is not yet satisfactory.Among various regimens, the combinations of paclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen have become two important ones.
Paclitaxel can bind to microtubules and induces hyperstabilization leading to cell cycle arrest and apoptosis. The response rate of GC patients to paclitaxel is 20%-25%. Oxaliplatin is a third-generation diaminocyclohexane platinum compound which has a wide range of antitumor activities, appearing to have a better safety profile than cisplatin. The response rate of mGC patients to FOLFOX-4 regimen is 38%-43%. S-1 is an oral anti-cancer agent composed of tegafur, 5-chloro-2,4-dihydroxypyridine, and oteracil potassium. The applying of S-1 as adjuvant chemotherapy for mGC can improve the overall survival (OS) and relapse-free survival. A meta-analysis showed OS favored S-1-based chemotherapy over 5-FU-based chemotherapy in mGC. S-1 plus oxaliplatin (SOX) have showed non-inferiority to S-1 plus cisplatin in PFS and that the treatment was well tolerated in patients with mGC.
No study is available comparing the efficacy and safety of TOF and SOX regimens. So the investigators performed the present randomized, controlled study to compare the efficacy and safety of the two regimens in mGC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOF Group | Active comparator | Drug: paclitaxel+oxaliplatin+fluorouracilPatients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil" |
| SOX Group | Experimental | Drug: oxaliplatin+S1The patients in the SOX group received chemotherapy with 'oxaliplatin+S1' |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- pathologically confirmed mGC (stage IV)
- ages between 20 and 80 years
- measurable or assessable lesions by imaging studies according to the RECIST guideline 21
- no prior chemotherapy except for postoperative adjuvant chemotherapy for more than 12 months before entry into the study
- Eastern Cooperative Oncology Group (ECOG) performance status score less than 3
Key exclusion criteria (8 listed)
- preexisted peripheral toxicity ≥ grade 2 of the National Cancer Institute Common Toxicity Criteria
- concurrent or prior malignancy
- central nervous system metastases
- concurrent treatment that interfered with the study evaluation
- active infection
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 |
|---|---|---|
| paclitaxel+oxaliplatin+fluorouracilAlso: TOF regimenPatients treated with "paclitaxel+oxaliplatin+fluorouracil": paclitaxel (135 mg/m2 iv) on day 1, oxaliplatin (100 mg/m2 iv) on day 1, fluorouracil (500 mg/m2 continuous iv) on day 1-5twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14. | Drug | TOF Group |
| oxaliplatin+S1Also: SOX regimenPatients treated with "oxaliplatin+S1": oxaliplatin (130 mg/m2 iv) on day 1 and S-1 (40 mg twice/day for body surface area < 1.25 m2 and 60 mg twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14 | Drug | SOX Group |
Primary outcome
Tumor respone
Time frame: 8 weeks
According to the RECIST guideline
1 secondary outcome
Side-effect
Time frame: 8 weeks
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 13 May 2015.
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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.
Changping Wu, M.D. study director
the First People' Hospital of Changzhou
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing paclitaxel+oxaliplatin+fluorouracil and oxaliplatin+S1 in people with Gastric Cancer, run by The First People's Hospital of Changzhou.
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 11 inclusion and 8 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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.
What does the primary outcome measure?
Tumor respone (time frame: 8 weeks). 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 13 May 2015.