Locally Advanced Gastric CarcinomaPhase 3PresidentNCT03223740
Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy
A Phase 3 study testing Arm 1 pre-operative chemoradiation and Arm 2 post operative chemoradiation in people with Locally Advanced Gastric Carcinoma, run by Sichuan Provincial People's Hospital at 3 sites in China.
Trial summary
Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Carcinoma
- What is being tested?
- Arm 1 pre-operative chemoradiation and Arm 2 post operative chemoradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 3 sitesChina
- Study dates
- Sep 2016to Oct 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
- EUS or MRI stage T3-4, any N, M0.
- Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
- Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
- No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
- Patients must have a life expectancy of at least 16 weeks.
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- Performance status of < 2 (Zubrod scale).
- No biopsy proof of lymph node metastases outside the study field.
- No evidence of metastatic disease to distant organs.
- No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer.
- No uncontrolled or severe cardiac disease, diabetes or hypertension.
- Signed study-specific consent form prior to study entry.
Who cannot join
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
- Cardiac failure or Sever Pulmonary disease
- Patients with impaired gastrointestinal absorption for whatever reason
- Patients medically unfit for cisplatin or taxol chemotherapy
Trial locations and contacts
3 sites in 1 country.
China3 sites, 2 recruiting
- Recruiting
friendship Hospital
Chengdu, Sichuan, 610000
lili deng, MD, +8613880926676
- Recruiting
ziyang People's Hospital
Siyang, Sichuan
min wei, MD, +8613980386078
- Active, not recruiting
Xijing Hospital, GI institute
Xi’an, Shanxi, 710032
About this study
Official title: A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.
- Conditions
- Locally Advanced Gastric Carcinoma
- Being tested
- Arm 1 pre-operative chemoradiation, Arm 2 post operative chemoradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 pre-operative chemoradiationOther
Chemotherapy 1:
First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5.
Chemoradiotherapy:
At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks.
Chemotherapy2:
Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition.
2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29.
Arm 2 post operative chemoradiationOther
Surgical resection, a D2 resection is encouraged.
Chemotherapy 1:
All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22.
Chemoradiotherapy:
At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks.
Chemotherapy2:
2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 pre-operative chemoradiation | Experimental | Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2 Receives: Other: Arm 1 pre-operative chemoradiation |
| Arm 2 post operative chemoradiation | Active comparator | Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2 Receives: Other: Arm 2 post operative chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: up to 5 year
Secondary outcomes (2)
Overall Survival
Measured: up to 5 year
R0 Resection Rate
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study startSep 2016
- Primary completionSep 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CarcinomaStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xijing Hospital
- Responsible party
- Principal investigator, ming zeng, MD, Sichuan Provincial People's Hospital
- Investigators
- Ming Zeng, MD PhD, Study chair, Sichuan Academy of Medical ScienceHongwei Zhang, MD PhD, Study chair, Xijing Hosptial, GI institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223740
- Sponsor's protocol ID
- President Trial
- Acronym
- President
- Status last verified
- Aug 2017
- First submitted
- 18 Jul 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
- ClinicalTrials.gov ID
- NCT03223740
- Acronym / sponsor ID
- President / President Trial
- Conditions
- Locally Advanced Gastric Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Xijing Hospital
- Study start
- Sep 2016
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 21 Jul 2017 (actual)
- 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.
Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 pre-operative chemoradiation | Experimental | Other: Arm 1 pre-operative chemoradiationChemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2 |
| Arm 2 post operative chemoradiation | Active comparator | Other: Arm 2 post operative chemoradiationSurgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
- EUS or MRI stage T3-4, any N, M0.
- Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
- Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
- No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
Key exclusion criteria (8 listed)
- Evidence of metastatic disease
- Prior chemotherapy or radiotherapy
- Patients with a past history of cancer
- Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
- Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
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 |
|---|---|---|
| Arm 1 pre-operative chemoradiationChemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29. | Other | Arm 1 pre-operative chemoradiation |
| Arm 2 post operative chemoradiationSurgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29 | Other | Arm 2 post operative chemoradiation |
Primary outcome
Progression Free Survival
Time frame: up to 5 year
2 secondary outcomes
Overall Survival
Time frame: up to 5 year
R0 Resection Rate
Time frame: At time of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ming Zeng, MD PhD study chair
Sichuan Academy of Medical Science
Hongwei Zhang, MD PhD study chair
Xijing Hosptial, GI institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arm 1 pre-operative chemoradiation and Arm 2 post operative chemoradiation in people with Locally Advanced Gastric Carcinoma, run by Sichuan Provincial People's Hospital at 3 sites in China.
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 12 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: status not confirmed, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Peng, MD PhD (008617708130617, pengqian0522@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: up to 5 year). 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 21 Aug 2017.