Esophageal CancerPhase 2NCT00400114
Sutent Following Chemotherapy, Radiation and Surgery For Resectable Esophageal Cancer
A Phase 2 study testing Irinotecan, Cisplatin and Radiation in people with Esophageal Cancer, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Irinotecan, Cisplatin and Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Sep 2006to 19 Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin).
- Tumors must be technically resectable.
- Clinical T1N1M0, T2-3 N0-1 M0
- Performance status ECOG 0-1
- Medically fit for chemotherapy, radiation and esophagectomy
Who cannot join
- In situ or clinical T1N0M0, and stage IV (M1a orM1b)
- Cervical esophageal tumors (within 20 cm of the incisors)
- Age <18 or >70
- Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
- known or suspected drug or alcohol abuse
- Prior treatment for this malignancy except esophageal stenting
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
University Health Network (Princess Margaret & Toronto General Hospitals)
Toronto, Ontario, M5G 2C4
About this study
Official title: Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)
The purpose of this study is to see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.
Read the detailed description
Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. This has the potential to improve survival. The primary endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and clinical data suggest that Sutent will have activity in esophageal cancer, as the results of Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer. Therefore, by extrapolation from promising phase I, II and III Sutent trials we propose to translate the target effects achieved with Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- Irinotecan, Cisplatin, Radiation, Surgery, sunitinib (Sutent)
- Keywords
- esophageal, esophagus, cancer, sutent, sunitinib
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Irinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
CisplatinDrug
Cisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8
RadiationProcedure or surgery
Radiation 50 Gy (weeks 4-9)
SurgeryProcedure or surgery
Esophagectomy
sunitinib (Sutent)Drug
sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op.
| Study group | Role | What they receive |
|---|---|---|
| sunitinib | Experimental | Not described Receives: Drug: Irinotecan; Drug: Cisplatin; Procedure: Radiation; Procedure: Surgery; Drug: sunitinib (Sutent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility and efficacy of adjuvant Sutent therapy after concurrent neoadjuvant therapy with Irinotecan, Cisplatin, external beam conformal radiotherapy plus surgery for potentially resectable esophageal cancer.
Measured: 5 yrs
Secondary outcomes (5)
To assess the impact of adjuvant targeted therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III, and to compare these data to our current completed trial in the same patient population
Measured: 5 yrs
To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III
Measured: 2 yrs
To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease
Measured: 5 yrs
Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol
Measured: 5 yrs
To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study start25 Sep 2006
- Primary completion19 Sep 2016
- Study completion19 Sep 2016
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 Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jennifer J Knox, MD M.Sc. FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400114
- Sponsor's protocol ID
- 06-0407-C
- Status last verified
- May 2017
- First submitted
- 15 Nov 2006
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Horgan AM, Darling G, Wong R, Guindi M, Liu G, Jonker DJ, Lister J, Xu W, MacKay HM, Dinniwell R, Kim J, Pierre A, Shargall Y, Asmis TR, Agboola O, Seely AJ, Ringash J, Wells J, Marginean EC, Haider M, Knox JJ. Adjuvant sunitinib following chemoradiotherapy and surgery for locally advanced esophageal cancer: a phase II trial. Dis Esophagus. 2016 Nov;29(8):1152-1158. doi: 10.1111/dote.12444. Epub 2015 Dec 10.
PubMed 26663741
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Sutent Following Chemotherapy, Radiation and Surgery For Esophageal Cancer, A Phase II Trial (ASSET)
- ClinicalTrials.gov ID
- NCT00400114
- Acronym / sponsor ID
- 06-0407-C
- Conditions
- Esophageal Cancer
- Keywords
- esophageal, esophagus, cancer, sutent, sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 25 Sep 2006 (actual)
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 19 Sep 2016 (actual)
- First posted
- 16 Nov 2006 (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 see whether or not the combination of cisplatin, irinotecan and radiation, followed by surgery, followed by oral Sutent, is effective and safe for patients with resectable esophageal cancer.
Detailed description
Survival outcomes for resectable esophageal cancer remain poor. Current data strongly support an adjuvant systemic strategy to improve time to progression and survival in this patient population. Adding a well-tolerated oral targeted therapy such as Sutent, after a combined chemo/radiation/surgery approach in this patient population has the potential to impact on the minimal residual disease left behind by relatively effective pre-operative chemoradiation and surgery. This has the potential to improve survival. The primary endpoint is to determine the feasibility and efficacy of adjuvant Sutent therapy (SU11248) after concurrent neoadjuvant therapy with irinotecan, cisplatin, external beam conformal radiotherapy plus surgery for potential resectable esophageal cancer. Preclinical and clinical data suggest that Sutent will have activity in esophageal cancer, as the results of Sutent activity in solid tumors appear to be superior to the results of other antiangiogenic compounds in development for esophageal cancer. Therefore, by extrapolation from promising phase I, II and III Sutent trials we propose to translate the target effects achieved with Sutent to reduce local and systemic therapy failure, and thus metastasis in esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib | Experimental | Drug: Irinotecan, Drug: Cisplatin, Procedure: Radiation, Procedure: Surgery, Drug: sunitinib (Sutent) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically proven squamous or adenocarcinoma or the esophagus >20 cm from the incisors, including GE junction tumors (unless of gastric origin).
- Tumors must be technically resectable.
- Clinical T1N1M0, T2-3 N0-1 M0
- Performance status ECOG 0-1
- Medically fit for chemotherapy, radiation and esophagectomy
Key exclusion criteria (6 listed)
- In situ or clinical T1N0M0, and stage IV (M1a orM1b)
- Cervical esophageal tumors (within 20 cm of the incisors)
- Age <18 or >70
- Participation in another concurrent clinical study involving study drug(s) or treatment with study drug within thirty days prior to the treatment on this study. Concurrent treatment with other experimental drugs or anticancer therapy
- known or suspected drug or alcohol abuse
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 |
|---|---|---|
| IrinotecanIrinotecan (50mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8 | Drug | sunitinib |
| CisplatinCisplatin (65mg/m2)once weekly in weeks 1, 2, 4, 5, 7, and 8 | Drug | sunitinib |
| RadiationRadiation 50 Gy (weeks 4-9) | Procedure or surgery | sunitinib |
| SurgeryEsophagectomy | Procedure or surgery | sunitinib |
| sunitinib (Sutent)sunitinib (Sutent), dose range of 12.5mg - 50mg OD x 1 year post op. | Drug | sunitinib |
Primary outcome
To determine the feasibility and efficacy of adjuvant Sutent therapy after concurrent neoadjuvant therapy with Irinotecan, Cisplatin, external beam conformal radiotherapy plus surgery for potentially resectable esophageal cancer.
Time frame: 5 yrs
5 secondary outcomes
To assess the impact of adjuvant targeted therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III, and to compare these data to our current completed trial in the same patient population
Time frame: 5 yrs
To characterize toxicity of targeted adjuvant therapy with Sutent after multimodality therapy for resected esophageal cancer stage II to III
Time frame: 2 yrs
To measure time-to-event efficacy variables including: Time to treatment failure and Time to progressive disease
Time frame: 5 yrs
Survival of patients with esophageal cancer stage II to III with adjuvant targeted therapy added to multimodality treatment protocol
Time frame: 5 yrs
To determine the pattern of relapse (local versus distant) with the addition of adjuvant targeted therapy to esophageal cancer multimodality therapy
Time frame: 5 yrs
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 8 May 2017.
- Background: PubMed 26663741Horgan AM, Darling G, Wong R, Guindi M, Liu G, Jonker DJ, Lister J, Xu W, MacKay HM, Dinniwell R, Kim J, Pierre A, Shargall Y, Asmis TR, Agboola O, Seely AJ, Ringash J, Wells J, Marginean EC, Haider M, Knox JJ. Adjuvant sunitinib following chemoradiotherapy and surgery for locally advanced esophageal cancer: a phase II trial. Dis Esophagus. 2016 Nov;29(8):1152-1158. doi: 10.1111/dote.12444. Epub 2015 Dec 10.
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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.
Jennifer J Knox, MD M.Sc. FRCPC principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Cisplatin and Radiation in people with Esophageal Cancer, run by University Health Network, Toronto at 2 sites in Canada.
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 5 inclusion and 6 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 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?
To determine the feasibility and efficacy of adjuvant Sutent therapy after concurrent neoadjuvant therapy with Irinotecan, Cisplatin, external beam conformal radiotherapy plus surgery for potentially resectable esophageal cancer. (time frame: 5 yrs). 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 NCT00400114, 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 8 May 2017.