Gastroesophageal Junction AdenocarcinomaPhase 2/3A-CNCT01962246
Preoperative Concurrent Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Esophagogastric Junction
A Phase 2/3 study testing Oxaliplatin; Capecitabine and Oxaliplatin; Capecitabine; concurrent radiotherapy in people with Gastroesophageal Junction Adenocarcinoma, run by Hebei Medical University at 1 site in China.
Trial summary
Stage I：preoperative therapy Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone; A regimen of Capecitabine plus… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Oxaliplatin; Capecitabine and Oxaliplatin; Capecitabine; concurrent radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Aug 2021
- 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
- Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria)
- Histologically confirmed primary adenocarcinoma
- T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0，
- ECOG performance status ≦2
- AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia.
- The classification of AEG type I, type II and type III AEG type I: adenocarcinoma of the distal esophagus,which usually arises from an area with specialized intestinal metaplasia of the esophagus, i Barrett's esophagus, and may infiltrate the esophago-gastric junction from above;
- AEG type II: true carcinoma of the cardia, arising from the cardia epithelium or short segments with intestinal metaplasia at the esophago-gastric junction;
- AEG type III: subcardial gastric carcinoma, which infiltrates the esophago-gastric junction and distal esophagus from below.
Who cannot join
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- Patients with primary carcinomas of the esophagus.
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- Patients with evidence of metastatic disease are not eligible.
- Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
- Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
- History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Concurrent Radiotherapy in Patients With Potentially Resectable Adenocarcinoma of Gastroesophageal Cancer
Stage I：preoperative therapy
- Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy
- Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone;
- A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- Oxaliplatin; Capecitabine, Oxaliplatin; Capecitabine; concurrent radiotherapy
- Keywords
- Capecitabine, Oxaliplatin, Preoperative Concurrent Chemoradiotherapy, Gastroesophageal Junction Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin; CapecitabineDrug
Also called Xeloda, Oxaliplatin
Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation
Oxaliplatin; Capecitabine; concurrent radiotherapyOther
Also called Xeloda, Oxaliplatin, XRT
Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT
| Study group | Role | What they receive |
|---|---|---|
| postoperative chemotherapy,XELOX | Active comparator | Not described Receives: Drug: Oxaliplatin; Capecitabine |
| Preoperative Concurrent Chemoradiotherapy | Experimental | Not described Receives: Other: Oxaliplatin; Capecitabine; concurrent radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival(DFS)
Measured: 3 year
Secondary outcomes (7)
R0-resection rate
Measured: within 3 weeks after surgery
Objective response rate (ORR)
Measured: within 3 weeks after surgery
Disease control rate (DCR)
Measured: within 3 weeks after surgery
Down-staging Rate
Measured: within 3 weeks after surgery
Overall survival (OS)
Measured: 3years
Adverse events
Side effects during observation] Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 2.0. The number of Participants with adverse events will be recorded at each treatment visit.
Measured: 3 year
Death related to operation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startFeb 2012
- Primary completionFeb 2020
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies 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
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
- Investigators
- Qun Zhao, Doctor, Principal investigator, Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962246
- Sponsor's protocol ID
- Alien-Craft
- Acronym
- A-C
- Status last verified
- Feb 2022
- First submitted
- 22 Jul 2012
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Tian Y, Wang J, Qiao X, Zhang J, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Yang P, Zhao Q. Long-Term Efficacy of Neoadjuvant Concurrent Chemoradiotherapy for Potentially Resectable Advanced Siewert Type II and III Adenocarcinomas of the Esophagogastric Junction. Front Oncol. 2021 Nov 11;11:756440. doi: 10.3389/fonc.2021.756440. eCollection 2021.
PubMed 34858829
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Concurrent Radiotherapy in Patients With Potentially Resectable Adenocarcinoma of Gastroesophageal Cancer
- ClinicalTrials.gov ID
- NCT01962246
- Acronym / sponsor ID
- A-C / Alien-Craft
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Keywords
- Capecitabine, Oxaliplatin, Preoperative Concurrent Chemoradiotherapy, Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2020 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 14 Oct 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.
Stage I：preoperative therapy
- Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy
- Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone;
- A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative chemotherapy,XELOX | Active comparator | Drug: Oxaliplatin; Capecitabine |
| Preoperative Concurrent Chemoradiotherapy | Experimental | Other: Oxaliplatin; Capecitabine; concurrent radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria)
- Histologically confirmed primary adenocarcinoma
- T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3M0，
- ECOG performance status ≦2
- AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia.
Key exclusion criteria (8 listed)
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- Patients with primary carcinomas of the esophagus.
- Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- Patients with evidence of metastatic disease are not eligible.
- Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
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 |
|---|---|---|
| Oxaliplatin; CapecitabineAlso: Xeloda, OxaliplatinCapecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation | Drug | postoperative chemotherapy,XELOX |
| Oxaliplatin; Capecitabine; concurrent radiotherapyAlso: Xeloda, Oxaliplatin, XRTCapecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT | Other | Preoperative Concurrent Chemoradiotherapy |
Primary outcome
Disease-free survival(DFS)
Time frame: 3 year
7 secondary outcomes
R0-resection rate
Time frame: within 3 weeks after surgery
Objective response rate (ORR)
Time frame: within 3 weeks after surgery
Disease control rate (DCR)
Time frame: within 3 weeks after surgery
Down-staging Rate
Time frame: within 3 weeks after surgery
Overall survival (OS)
Time frame: 3years
Adverse events
Time frame: 3 year
Death related to operation
Time frame: 4 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 21 Feb 2022.
- Derived from this study: PubMed 34858829Tian Y, Wang J, Qiao X, Zhang J, Li Y, Fan L, Zhang Z, Zhao X, Tan B, Wang D, Yang P, Zhao Q. Long-Term Efficacy of Neoadjuvant Concurrent Chemoradiotherapy for Potentially Resectable Advanced Siewert Type II and III Adenocarcinomas of the Esophagogastric Junction. Front Oncol. 2021 Nov 11;11:756440. doi: 10.3389/fonc.2021.756440. eCollection 2021.
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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.
Qun Zhao, Doctor principal investigator
Hebei Medical University
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 Oxaliplatin; Capecitabine and Oxaliplatin; Capecitabine; concurrent radiotherapy in people with Gastroesophageal Junction Adenocarcinoma, run by Hebei Medical 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 8 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 21 Feb 2022. 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?
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?
Disease-free survival(DFS) (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962246, which also lists 1 linked publication.
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 Feb 2022.