Stomach CancerPhase 1/2CORGINCT01016639
Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
A Phase 1/2 study testing oxaliplatin, capecitabine, radiotherapy in people with Stomach Cancer and Gall Bladder Cancer, run by Lund University Hospital at 5 sites in Sweden.
Trial summary
The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer
- What is being tested?
- oxaliplatin, capecitabine, radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 5 sitesSweden
- Study dates
- Jun 2003to Jul 2009
- Phase
- Phase 1/2
- 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
- Over 18 years of age
- Measurable disease according to RECIST
- ECOG Performance Status 0-1
- ANC over 1.5 x 10 9/L
- Platelets over 100 x 10 9/L
- Creatinine less than 1.5 x ULN
Show all 9Show fewer
- Bilirubin less than 1.5 x ULN
- ALT less than 2.5 x ULN
- Signed informed concent
Who cannot join
- Prior radiotherapy to the same local
- Prior chemotherapy for locally advanced or metastatic disease
- Pregnancy or breast feeding
- Peripheral neuropathy more than grade 1
- Uncontrolled diarrhéa
- Other serious uncontrolled concomitant illness
- Lymph node metastasis that can not be included in the GTV (gross tumor volume), without exceeding the stipulated radiotherapy doses in organs at risk
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Centralsjukhuset, Dept of Oncology
Karlstad
University Hospital Lund
Lund
University Hospital Malmö, Dept of Oncology
Malmö
Karolinska University Hospital
Stockholm
Akademiska Sjukhuset
Uppsala
About this study
Official title: Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts- gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer.
CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy dose finding study, followed by a phase II part to establish response rates. All subjects receives radiotherapy concommitant.
CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.
- Conditions
- Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer, Pancreas Cancer, Colorectal Cancer
- Being tested
- oxaliplatin, capecitabine, radiotherapy
- Keywords
- Stomach cancer, Gall bladder cancer, Bile ductus cancer, Pancreas cancer, Colorectal cancer, Chemo radiotherapy, Phase I-II, Oxaliplatin, Capecitabine, Response
- Medical subject headings
- Stomach Neoplasms, Gallbladder Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatin, capecitabine, radiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiotherapy | Experimental | Not described Receives: Other: oxaliplatin, capecitabine, radiotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJun 2003
- Primary completionJul 2007
- Study completionJul 2009
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Sanofi-Synthelabo
- Responsible party
- Sponsor
- Investigators
- Anders Johnsson, MD, PhD, Principal investigator, University Hospital Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016639
- Sponsor's protocol ID
- Version1
- Acronym
- CORGI
- Status last verified
- Oct 2011
- First submitted
- 18 Nov 2009
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Capecitabine and Oxaliplatin in Combination With Radiotherapy in Patients With Unresectable Gastro-Intestinal Cancer
- ClinicalTrials.gov ID
- NCT01016639
- Acronym / sponsor ID
- CORGI / Version1
- Conditions
- Stomach Cancer, Gall Bladder Cancer, Bile Ductus Cancer, Pancreas Cancer, Colorectal Cancer
- Keywords
- Stomach cancer, Gall bladder cancer, Bile ductus cancer, Pancreas cancer, Colorectal cancer, Chemo radiotherapy, Phase I-II, Oxaliplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Sanofi-Synthelabo
- Study start
- Jun 2003
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 Nov 2009 (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.
The purpose with this study is to evaluate treatment with radio chemotherapy (oxaliplatin and capecitabine) given concommitant with radiotherapy in patients with gastrointestinal tumors. The trial consists ot two separate studies; CORGI-U in patients with stomach- bile ducts- gallbladder and pancreas cancer, and CORGI-L in patients with colorectal cancer.
CORGI-U will be designed as a phase-I-II-study,in which the first part will be a chemotherapy dose finding study, followed by a phase II part to establish response rates. All subjects receives radiotherapy concommitant.
CORGI-L is a phase II trial, in which patients are treated with chemotherapy at fixed doses with radiotherapy concommitant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemoradiotherapy | Experimental | Other: oxaliplatin, capecitabine, radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 18 years of age
- Measurable disease according to RECIST
- ECOG Performance Status 0-1
- ANC over 1.5 x 10 9/L
- Platelets over 100 x 10 9/L
Key exclusion criteria (7 listed)
- Prior radiotherapy to the same local
- Prior chemotherapy for locally advanced or metastatic disease
- Pregnancy or breast feeding
- Peripheral neuropathy more than grade 1
- Uncontrolled diarrhéa
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, capecitabine, radiotherapy | Other | Chemoradiotherapy |
Primary outcome
Not reported in the source record.
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 17 Oct 2011.
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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.
Anders Johnsson, MD, PhD principal investigator
University Hospital Lund
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing oxaliplatin, capecitabine, radiotherapy in people with Stomach Cancer and Gall Bladder Cancer, run by Lund University Hospital at 5 sites in Sweden.
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 9 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: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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.
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 17 Oct 2011.