Esophageal CancerPhase 2NCT00316862
Cisplatin, Irinotecan, and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
A Phase 2 study testing cisplatin, irinotecan hydrochloride and therapeutic conventional surgery in people with Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 24 sites in United States.
Trial summary
This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- cisplatin, irinotecan hydrochloride and therapeutic conventional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 24 sitesUnited States
- Study dates
- Feb 2006to 15 Oct 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No history of clinically significant ventricular arrhythmia requiring ongoing medication with antiarrhythmics
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelet count >= 100,000/ul
- Hemoglobin >= 9 gm/dl
- Serum creatinine =< upper limit of normal (ULN)
- Total serum bilirubin =< 1.5 mg/dl
- Forced expiratory volume in 1 second (FEV-1) >= 1.2 liters OR >= 35% of normal as a value that is indexed to body size
- Pulmonary function tests (PFT) >= 1.2 liters OR >= 35% of normal as a value that is indexed to body size
Who cannot join
None listed.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, 04401
Mountainview Medical
Berlin Corners, Vermont, 05602
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, 03301
Elkhart General Hospital
Elkhart, Indiana, 46515
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Howard Community Hospital
Kokomo, Indiana, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Lakes Region General Hospital
Laconia, New Hampshire, 03246
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, 03103
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, 04074
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, 46601
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
About this study
Official title: A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer
This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan (irinotecan hydrochloride) followed by concurrent cisplatin/irinotecan and radiation therapy.
SECONDARY OBJECTIVES:
- To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography (PET) scan.
II. To evaluate the toxicity and tolerability of therapy, including surgical morbidity and mortality.
III. To determine the overall survival, disease free survival, and pattern of failure.
OUTLINE:
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
- Conditions
- Esophageal Cancer
- Being tested
- cisplatin, irinotecan hydrochloride, therapeutic conventional surgery, radiation therapy
- Keywords
- adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Given IV
Given IV
therapeutic conventional surgeryProcedure or surgery
Undergo Surgery
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation
| Study group | Role | What they receive |
|---|---|---|
| Treatment (chemotherapy, chemoradiotherapy, surgery) | Experimental | INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor. Receives: Drug: cisplatin; Drug: irinotecan hydrochloride; Procedure: therapeutic conventional surgery; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery
A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor
Measured: Up to 5 years
Secondary outcomes (6)
Utility of Early PET Imaging in Predicting Response to Treatment
Measured: Up to 55 days
Disease-free Survival
Measured: Up to 5 years
Overall Survival
Measured: Up to 5 years
Patterns of Failure
Measured: Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis
Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity
Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2012
- Study completion15 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David H. Ilson, MD, PhD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316862
- Sponsor's protocol ID
- CALGB-80302
- Other IDs
- CDR0000468495, NCI-2009-00491, U10CA180821
- Status last verified
- Apr 2018
- First submitted
- 19 Apr 2006
- Last updated
- 8 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00316862
- Acronym / sponsor ID
- CALGB-80302
- Conditions
- Esophageal Cancer
- Keywords
- adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- 15 Oct 2014 (actual)
- First posted
- 21 Apr 2006 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Detailed description
PRIMARY OBJECTIVES:
- To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan (irinotecan hydrochloride) followed by concurrent cisplatin/irinotecan and radiation therapy.
SECONDARY OBJECTIVES:
- To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography (PET) scan.
II. To evaluate the toxicity and tolerability of therapy, including surgical morbidity and mortality.
III. To determine the overall survival, disease free survival, and pattern of failure.
OUTLINE:
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (chemotherapy, chemoradiotherapy, surgery) | Experimental | Drug: cisplatin, Drug: irinotecan hydrochloride, Procedure: therapeutic conventional surgery, Radiation: radiation therapyINDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- No history of clinically significant ventricular arrhythmia requiring ongoing medication with antiarrhythmics
- Absolute neutrophil count (ANC) >= 1,500/ul
- Platelet count >= 100,000/ul
- Hemoglobin >= 9 gm/dl
- Serum creatinine =< upper limit of normal (ULN)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| cisplatinGiven IV | Drug | Treatment (chemotherapy, chemoradiotherapy, surgery) |
| irinotecan hydrochlorideGiven IV | Drug | Treatment (chemotherapy, chemoradiotherapy, surgery) |
| therapeutic conventional surgeryUndergo Surgery | Procedure or surgery | Treatment (chemotherapy, chemoradiotherapy, surgery) |
| radiation therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation | Radiation | Treatment (chemotherapy, chemoradiotherapy, surgery) |
Primary outcome
Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery
Time frame: Up to 5 years
A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor
6 secondary outcomes
Utility of Early PET Imaging in Predicting Response to Treatment
Time frame: Up to 55 days
Disease-free Survival
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Patterns of Failure
Time frame: Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis
Time frame: Up to 5 years
Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David H. Ilson, MD, PhD study chair
Memorial Sloan Kettering Cancer Center
24 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 cisplatin, irinotecan hydrochloride and therapeutic conventional surgery in people with Esophageal Cancer, run by Alliance for Clinical Trials in Oncology at 24 sites in United States.
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 0 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 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery (time frame: Up to 5 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 May 2018.