Gastroesophageal Junction AdenocarcinomaPhase 2/3NCT02193594
Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
A Phase 2/3 study testing Preoperative concurrent chemoradiotherapy, Radical D2 total gastrectomy and Adjuvant chemotherapy in people with Gastroesophageal Junction Adenocarcinoma, run by Peking University at 1 site in China.
Trial summary
Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Preoperative concurrent chemoradiotherapy, Radical D2 total gastrectomy and Adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to May 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the gastroesophageal junction.
- Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
- Eastern Cooperative Oncology Group (ECOG) performance status≤2.
- Informed consent obtained.
Who cannot join
- Combined with other malignant tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status>2.
- Combined with severe organ dysfunction.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Jiafu Ji, M.D. contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Haidian District, Beijing Municipality, 100142
Shuangxi Li, M.D., lishuangxi@outlook.com
Jiafu Ji, M.D.
About this study
Official title: Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- Preoperative concurrent chemoradiotherapy, Radical D2 total gastrectomy, Adjuvant chemotherapy
- Keywords
- Preoperative concurrent chemoradiotherapy, Neoadjuvant chemoradiotherapy, Gastroesophageal junction adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative concurrent chemoradiotherapyRadiation
Also called CCRT, Eloxatin®, S-1®
The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.
Radical D2 total gastrectomyProcedure or surgery
Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.
Adjuvant chemotherapyDrug
Also called Eloxatin®, S-1®
Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CCRT group | Experimental | The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles. Receives: Radiation: Preoperative concurrent chemoradiotherapy; Procedure: Radical D2 total gastrectomy; Drug: Adjuvant chemotherapy |
| CT group | Active comparator | The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles. Receives: Procedure: Radical D2 total gastrectomy; Drug: Adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's survival time and recurrence time
3-year overall survival
1-year and 3-year recurrence free survival
Measured: Up to 3 years
Secondary outcomes (1)
The number of patients with complications
the morbidity and mortality rates within 30 days after the day of operation
Measured: Within 30 days after the day of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2017 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University People's Hospital, Beijing Friendship Hospital
- Responsible party
- Principal investigator, Jiafu Ji, Peking University
- Investigators
- Jiafu Ji, M.D., Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193594
- Sponsor's protocol ID
- CRADLE
- Status last verified
- Jun 2015
- First submitted
- 8 Jul 2014
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02193594
- Acronym / sponsor ID
- CRADLE
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Keywords
- Preoperative concurrent chemoradiotherapy, Neoadjuvant chemoradiotherapy, Gastroesophageal junction adenocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking University People's Hospital, Beijing Friendship Hospital
- Study start
- Jan 2014
- Primary completion
- Sep 2017 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 17 Jul 2014 (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.
Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCRT group | Experimental | Radiation: Preoperative concurrent chemoradiotherapy, Procedure: Radical D2 total gastrectomy, Drug: Adjuvant chemotherapyThe patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles. |
| CT group | Active comparator | Procedure: Radical D2 total gastrectomy, Drug: Adjuvant chemotherapyThe patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven adenocarcinoma of the gastroesophageal junction.
- Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.
- Eastern Cooperative Oncology Group (ECOG) performance status≤2.
- Informed consent obtained.
Key exclusion criteria (4 listed)
- Combined with other malignant tumors.
- Eastern Cooperative Oncology Group (ECOG) performance status>2.
- Combined with severe organ dysfunction.
- Pregnancy
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 |
|---|---|---|
| Preoperative concurrent chemoradiotherapyAlso: CCRT, Eloxatin®, S-1®The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week. | Radiation | CCRT group |
| Radical D2 total gastrectomyWithin 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization. | Procedure or surgery | CCRT group, CT group |
| Adjuvant chemotherapyAlso: Eloxatin®, S-1®Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy. | Drug | CCRT group, CT group |
Primary outcome
The patient's survival time and recurrence time
Time frame: Up to 3 years
3-year overall survival 1-year and 3-year recurrence free survival
1 secondary outcome
The number of patients with complications
Time frame: Within 30 days after the day of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 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.
Jiafu Ji, M.D. contact
Jiafu Ji, M.D. principal investigator
Peking University Cancer Hospital & Institute
1 site 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 Preoperative concurrent chemoradiotherapy, Radical D2 total gastrectomy and Adjuvant chemotherapy in people with Gastroesophageal Junction Adenocarcinoma, run by Peking University 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 4 inclusion and 4 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 Jun 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 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 Jiafu Ji, M.D. (jiafuj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's survival time and recurrence time (time frame: Up to 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 8 Jun 2015.