Stomach CancerPhase 2NCT01618474
Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients
A Phase 2 study testing DX and XELOX in people with Stomach Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer
- What is being tested?
- DX and XELOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a post operation histologically confirmed gastric or esophagogastric junction adenocarcinoma;
- curative D2 or D2+ operation had been performed, and the pathological stage post operation was verified as IIIb or IIIc;
- no adjuvant chemotherapy before or after operation;
- Karnofsky performance status scale ≥ 70;
- prior adjuvant chemotherapy that did not include taxanes and S-1;
- white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dL, serum bilirubin level < 1.5 of the upper limit of normal (ULN) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g/L, serum creatinine ≤ 1.5 ULN; and
- normal cardiac function with no severe heart disease.
Who cannot join
- Major exclusion criteria were as follows:
- pregnancy or breast feeding;
- past history of allergy to taxanes, platinum and 5-fluorouracil or their analogues;
- radiotherapy for all measurable target lesions;
- obstructive bowel disease;
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; and
- concomitant treatment with other anticancer drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc)
This trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.
Read the detailed description
Operation is the only curative treatment for gastric cancer patients. However, the rate of recurrence is high up to 60%. The 5 year's overall survival of patient at stage IIIb or more advanced stage is still poor and approximately 8-28%. Adjuvant chemotherapy is critical for improving efficacy further. Unfortunately, the optimal adjuvant regimen is not identified yet. The standard adjuvant treatments of American and European patients are not accepted widely in Asia area because of different operation procedure and patient's tolerability. Results of two critical trials indicated that S-1 alone as Japanese standard adjuvant chemotherapy could not improve the survival of stage IIIb advanced stage gastric cancer patients while the Korean standard regimen XELOX could. This implied that the more intensive chemotherapy must be used for the patients with higher risk of relapse. The proportion of the stage IIIb-IIIc Chinese gastric cancer patients is much larger than that of Japan and Korean. However, no randomized trial focusing on the extremely high risk of relapse stage IIIb and stage IIIc patients has been performed, and the standard adjuvant chemotherapy regimen is not clear and needs to be investigated.
Docetaxel based combination is one of the most effective regimens for advanced gastric cancer. The combination of docetaxel and 5-FU was found to have a similar efficacy to ECF regimen along with milder toxicity. Capecitabine has been proved to be a good alternative to infusional 5-FU. So, docetaxel plus capecitabine seems to be a promising adjuvant regimen for high risk stage IIIb-IIIc gastric cancer patients. But it still needs to be verified.
This trial is going to evaluate the efficacy and safety of two regimens of DX and XELOX as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.
- Conditions
- Stomach Cancer
- Being tested
- DX, XELOX
- Keywords
- gastric cancer, adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXDrug
Also called Docetaxel, Xeloda
Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.
XELOXDrug
Also called Eloxatin, XEloda
oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles
| Study group | Role | What they receive |
|---|---|---|
| DX | Experimental | DX: Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles. Receives: Drug: DX |
| XELOX | Active comparator | XELOX: oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
DFS was difined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
Measured: 3 years
Secondary outcomes (2)
overall survival
OS was defined as the length of time from the date of randomization to the date of death of vaious reasons
Measured: 3 years
CTC negative conversion rate
CTC negative conversion rate was defined as the proportion of the patients whose positive circulating tumor cell turns to be negative after adjuvant chemotherapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dingzhi Huang, M.D., Principal investigator, Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618474
- Sponsor's protocol ID
- CIH-HDZ-201205001
- Status last verified
- May 2012
- First submitted
- 27 May 2012
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial of Adjuvant Chemotherapy for High Risk Gastric Cancer Patients (IIIb-IIIc)
- ClinicalTrials.gov ID
- NCT01618474
- Acronym / sponsor ID
- CIH-HDZ-201205001
- Conditions
- Stomach Cancer
- Keywords
- gastric cancer, adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jun 2012 (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 trial is going to evaluate the efficacy and safety of two regimens of DX (docetaxel plus capecitabine)and XELOX (oxaliplatin plus capecitabine)as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.
Detailed description
Operation is the only curative treatment for gastric cancer patients. However, the rate of recurrence is high up to 60%. The 5 year's overall survival of patient at stage IIIb or more advanced stage is still poor and approximately 8-28%. Adjuvant chemotherapy is critical for improving efficacy further. Unfortunately, the optimal adjuvant regimen is not identified yet. The standard adjuvant treatments of American and European patients are not accepted widely in Asia area because of different operation procedure and patient's tolerability. Results of two critical trials indicated that S-1 alone as Japanese standard adjuvant chemotherapy could not improve the survival of stage IIIb advanced stage gastric cancer patients while the Korean standard regimen XELOX could. This implied that the more intensive chemotherapy must be used for the patients with higher risk of relapse. The proportion of the stage IIIb-IIIc Chinese gastric cancer patients is much larger than that of Japan and Korean. However, no randomized trial focusing on the extremely high risk of relapse stage IIIb and stage IIIc patients has been performed, and the standard adjuvant chemotherapy regimen is not clear and needs to be investigated.
Docetaxel based combination is one of the most effective regimens for advanced gastric cancer. The combination of docetaxel and 5-FU was found to have a similar efficacy to ECF regimen along with milder toxicity. Capecitabine has been proved to be a good alternative to infusional 5-FU. So, docetaxel plus capecitabine seems to be a promising adjuvant regimen for high risk stage IIIb-IIIc gastric cancer patients. But it still needs to be verified.
This trial is going to evaluate the efficacy and safety of two regimens of DX and XELOX as adjuvant chemotherapy for stage IIIb-IIIc gastric cancer patients after curative D2/D2+ operation, and to investigate the optimal adjuvant regimen for such extremely high risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DX | Experimental | Drug: DXDX: Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles. |
| XELOX | Active comparator | Drug: XELOXXELOX: oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a post operation histologically confirmed gastric or esophagogastric junction adenocarcinoma;
- curative D2 or D2+ operation had been performed, and the pathological stage post operation was verified as IIIb or IIIc;
- no adjuvant chemotherapy before or after operation;
- Karnofsky performance status scale ≥ 70;
- prior adjuvant chemotherapy that did not include taxanes and S-1;
Key exclusion criteria (7 listed)
- pregnancy or breast feeding;
- past history of allergy to taxanes, platinum and 5-fluorouracil or their analogues;
- radiotherapy for all measurable target lesions;
- obstructive bowel disease;
- past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; and
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 |
|---|---|---|
| DXAlso: Docetaxel, XelodaDocetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles. | Drug | DX |
| XELOXAlso: Eloxatin, XElodaoxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles | Drug | XELOX |
Primary outcome
disease free survival
Time frame: 3 years
DFS was difined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
2 secondary outcomes
overall survival
Time frame: 3 years
CTC negative conversion rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 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.
Dingzhi Huang, M.D. principal investigator
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
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 DX and XELOX in people with Stomach Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 22 Dec 2015. 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 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 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?
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?
disease free survival (time frame: 3 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 22 Dec 2015.