Resectable Esophageal CancerPhase 2TRACCNCT00827671
Study of Combination of Cetuximab and Radiotherapy Added to the Standard Treatment for Oesophageal Adenocarcinoma
A Phase 2 study testing cetuximab and radiotherapy to oesophageal tumour in people with Resectable Esophageal Cancer, run by P.O. Witteveen at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Esophageal Cancer
- What is being tested?
- cetuximab and radiotherapy to oesophageal tumour
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Mar 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
- Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction
- Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.
- Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained.
- Weight loss < 10% in 0.5 yr
- WHO performance status 0-1
- No prior radiotherapy or chemotherapy for the adenocarcinoma of the oesophagus
Who cannot join
- Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ.
- Inadequate organ function as defined by:
- Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils < 1,5 109/L -platelets <100*109/L),
- Liver enzyme elevation (bili > 1,5*ULN - ASAT > 2,5*ULN - ALAT > 2,5*ULN) or
- Impaired renal function (creatinine clearance by cockcroft < 60 cc/min)
- Proteinuria >1,0gr/24hr
Show all 21Show fewer
- Tumour stage: M1a and/or tumour length > 8 cm and/or > 5 cm radially
- Major surgery within 4 weeks prior to the start of study treatment
- Bleeding disorder
- Known allergy to one of the study drugs used
- Use of any substance known to interfere with the chemotherapy clearance
- Previous radiotherapy to the chest
- Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
- Uncontrolled angina pectoris; cardiac failure or clinically significant arrhythmias
- Continuous use of immunosuppressive agents
- Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
- Prior exposure to anti-EGFR targeting agents.
- Hearing loss > 25 dB under normal
- Neurotoxicity > CTC grade 1
- Pregnancy or breast feeding
- Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
The purpose of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.
Read the detailed description
This study aims at developing a novel strategy to optimize the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. Surgery in combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin and 5-FU, as defined by the recent MAGIC trial, results in 13% increase in 5-yr survival. To improve the outcome of patients with this disease we hypothesize that the addition of pre-operative combined cetuximab-radiotherapy (cetux-RT) treatment could improve the outcome of this patient category through better local control.
- Conditions
- Resectable Esophageal Cancer
- Being tested
- cetuximab, radiotherapy to oesophageal tumour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
Also called erbitux, c225
cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment
radiotherapy to oesophageal tumourRadiation
45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative chemotherapy | Other | Not described Receives: Drug: cetuximab; Radiation: radiotherapy to oesophageal tumour |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete remission
determination of tumor residual cell content in surgical specimen
Measured: 1 month
Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
Measured: 6 months
Secondary outcomes (5)
Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0
Measured: 5 months
Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures
Measured: 4 weeks
Progression free survival and overall survival
Measured: 5 years
Define local (locoregional lymphnode metastasis as defined by TNM classification/ malignant peritonitis/ solid masses within the anatomic region of the esophagus) vs distant metastases as first manifestation of recurrence
Measured: 5 years
The number of R0 resection determined by the pathologist
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2015
- Study completionMar 2016
Why it stopped: Experimental treatment not feasible due to high rate of drop out
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 Resectable Esophageal 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- P.O. Witteveen
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor-investigator, P.O. Witteveen, UMC Utrecht
- Investigators
- M. P. Lolkema, MD/PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827671
- Sponsor's protocol ID
- NL23124.041.08
- Other IDs
- 2008-002203-13, 2008
- Acronym
- TRACC
- Status last verified
- Mar 2018
- First submitted
- 22 Jan 2009
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ubink I, van der Sluis P, Schipper M, Reerink O, Voest E, Borel-Rinkes I, Wijrdeman H, Vleggaar F, Agterof M, Overkleeft E, Siersema P, van Hillegersberg R, Lolkema MP. Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a single-center prospective phase II trial. Oncologist. 2014 Jan;19(1):32-3. doi: 10.1634/theoncologist.2013-0254. Epub 2013 Dec 12.
PubMed 24335595
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modality Treatment of Resectable Oesophageal Adenocarcinoma Using Peri-operative Chemotherapy With Additional Pre-operative Combined Radiotherapy and Cetuximab
- ClinicalTrials.gov ID
- NCT00827671
- Acronym / sponsor ID
- TRACC / NL23124.041.08
- Conditions
- Resectable Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Experimental treatment not feasible due to high rate of drop out
- Enrolment
- 12 participants (actual)
- Lead sponsor
- P.O. WitteveenUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Mar 2009 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jan 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 of this study is to determine whether the addition of the combination between cetuximab and radiotherapy to the standard chemotherapy for resectable oesophageal cancer is safe and adds efficacy.
Detailed description
This study aims at developing a novel strategy to optimize the treatment of oesophageal adenocarcinoma and gastro-oesophageal junctional tumors with curative intent. Surgery in combination with peri-operative chemotherapy, using the combination epirubicin, cisplatin and 5-FU, as defined by the recent MAGIC trial, results in 13% increase in 5-yr survival. To improve the outcome of patients with this disease we hypothesize that the addition of pre-operative combined cetuximab-radiotherapy (cetux-RT) treatment could improve the outcome of this patient category through better local control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative chemotherapy | Other | Drug: cetuximab, Radiation: radiotherapy to oesophageal tumour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven resectable adenocarcinoma of the lower oesophagus and gastric-oesophageal junction
- Tumour stage: T2-3 N0-1 M0, as assessed by endoscopic ultrasound and CT-scan of thorax and abdomen and ultrasound neck region. For the patients treated in this study the gastro-oesophageal junctional tumors will be staged as oesophageal tumors with respect to their lymphnode metastases.
- Age >18y and written informed consent after at least 4 days of deliberation time from the moment the patient information has been given and has been explained.
- Weight loss < 10% in 0.5 yr
- WHO performance status 0-1
Key exclusion criteria (21 listed)
- Previous malignancy other than basal cell carcinoma of the skin or local resection for cervical carcinoma in situ.
- Inadequate organ function as defined by:
- Inadequate haematology (Hb < 5,5 mmol/L (red blood cell transfusions are allowed to increase the Hb at the discretion of the investigator) - neutrophils < 1,5 109/L -platelets <100*109/L),
- Liver enzyme elevation (bili > 1,5*ULN - ASAT > 2,5*ULN - ALAT > 2,5*ULN) or
- Impaired renal function (creatinine clearance by cockcroft < 60 cc/min)
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 |
|---|---|---|
| cetuximabAlso: erbitux, c225cetuximab initial dose 400 mg/m2 iv 1 week before start radiotherapy and subsequent weekly doses of 250 mg/m2 iv for the duration of the radiation treatment | Drug | Pre-operative chemotherapy |
| radiotherapy to oesophageal tumour45 Gy delivered in 25 fractions of 1.8 Gy 5d/wk | Radiation | Pre-operative chemotherapy |
Primary outcome
pathological complete remission
Time frame: 1 month
determination of tumor residual cell content in surgical specimen
Resectability rate defined as the number of patients abke to undergo resection after neo-adjuvant treatment
Time frame: 6 months
5 secondary outcomes
Adverse events during neo-adjuvant treatment as defined by NIH CTCAE v3.0
Time frame: 5 months
Complications in the post-operative period (defined as 4 weeks after surgery) that can be attributed to surgical procedures
Time frame: 4 weeks
Progression free survival and overall survival
Time frame: 5 years
Define local (locoregional lymphnode metastasis as defined by TNM classification/ malignant peritonitis/ solid masses within the anatomic region of the esophagus) vs distant metastases as first manifestation of recurrence
Time frame: 5 years
The number of R0 resection determined by the pathologist
Time frame: after surgery
Results and safety
The study was stopped early (reason given: Experimental treatment not feasible due to high rate of drop out). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Derived from this study: PubMed 24335595Ubink I, van der Sluis P, Schipper M, Reerink O, Voest E, Borel-Rinkes I, Wijrdeman H, Vleggaar F, Agterof M, Overkleeft E, Siersema P, van Hillegersberg R, Lolkema MP. Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for resectable esophageal adenocarcinoma: a single-center prospective phase II trial. Oncologist. 2014 Jan;19(1):32-3. doi: 10.1634/theoncologist.2013-0254. Epub 2013 Dec 12.
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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.
M. P. Lolkema, MD/PhD principal investigator
UMC Utrecht
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 cetuximab and radiotherapy to oesophageal tumour in people with Resectable Esophageal Cancer, run by P.O. Witteveen at 1 site in Netherlands.
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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 9 Mar 2018. 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 Netherlands. 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?
The study was stopped early (reason given: Experimental treatment not feasible due to high rate of drop out). 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?
pathological complete remission (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT00827671, 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 9 Mar 2018.