Esophageal CarcinomaPhase 2NCT00590031
Phase II Trial of Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
A Phase 2 study testing Cisplatin, Irinotecan and External Beam Radiation Therapy in people with Esophageal Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Carcinoma
- What is being tested?
- Cisplatin, Irinotecan and External Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Dec 2009
- 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
- Patients must be able to sign the informed consent document.
Who cannot join
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
- Cervical esophageal tumors,
- Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
- Prior chemotherapy or radiation.
- Patients with evidence of metastatic disease are not eligible. This includes:
- Positive malignant cytology of the pleura, pericardium or peritoneum.
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- Radiographic evidence of distant organ involvement including lung, liver, bone, or brain.
- Patients with involvement of non-regional lymph nodes including supraclavicular or celiac lymph node metastases.
- Biopsy proven tumor invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. Recurrent laryngeal nerve or phrenic nerve paralysis,
- New York Heart Association Class III or 1V heart disease. Angina or myocardial infarction within the last 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics, or a history of a clinically significant conduction system abnormality.
- Severe co-morbid conditions including severe uncontrolled diabetes, uncontrolled hypertension, cerebral vascular disease, uncontrolled infection, or nonmalignant illness whose control may be jeopardized by the complications of this study treatment.
- Pregnant or lactating women are ineligible as the effect of the drugs used in this study on a fetus or newborn child are unknown. Premenopausal fertile females require a negative pregnancy test prior to study entry. Treatment may not begin until the results of the pregnancy tests are ascertained. Both sexes must use contraception while on this study.
- History of prior malignancy (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of entrance into this study.
- Patients with known Gilbert's Disease.
- Clinically significant hearing loss.
- Serum calcium_>12 mg/dl.
- 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 the requirements.
- Patients with any other concurrent medical or psychiatric condition or disease, which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.
- Conditions
- Esophageal Carcinoma
- Being tested
- Cisplatin, Irinotecan, External Beam Radiation Therapy
- Keywords
- Esophageal Carcinoma, Cisplatin, Irinotecan, Radiation Therapy, 02-045
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12
IrinotecanDrug
Irinotecan will be given 65 mg/m2
External Beam Radiation TherapyRadiation
will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | External Beam Radiation Therapy, Cisplatin, Irinotecan Receives: Drug: Cisplatin; Drug: Irinotecan; Radiation: External Beam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.
Measured: 2 years
Secondary outcomes (1)
Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startNov 2002
- Primary completionDec 2009
- Study completionDec 2009
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ilson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590031
- Sponsor's protocol ID
- 02-045
- Other IDs
- IND 65889
- Status last verified
- Dec 2015
- First submitted
- 26 Dec 2007
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Combined Modality Therapy for Esophageal Carcinoma: Cisplatin-Irinotecan Followed by Radiation Therapy With Concurrent Cisplatin and Irinotecan.
- ClinicalTrials.gov ID
- NCT00590031
- Acronym / sponsor ID
- 02-045
- Conditions
- Esophageal Carcinoma
- Keywords
- Esophageal Carcinoma, Cisplatin, Irinotecan, Radiation Therapy, 02-045
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Cisplatin, Drug: Irinotecan, Radiation: External Beam Radiation TherapyExternal Beam Radiation Therapy, Cisplatin, Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be able to sign the informed consent document.
Key exclusion criteria (19 listed)
- Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound, or CT scanning.
- Cervical esophageal tumors,
- Gastric cancers with minor involvement of the gastroesophageal junction or distal esophagus.
- Prior chemotherapy or radiation.
- Patients with evidence of metastatic disease are not eligible. This includes:
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 |
|---|---|---|
| Cisplatinpts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12 | Drug | 1 |
| IrinotecanIrinotecan will be given 65 mg/m2 | Drug | 1 |
| External Beam Radiation Therapywill be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period. | Radiation | 1 |
Primary outcome
Pathologic Complete Response
Time frame: 2 years
Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months.
1 secondary outcome
Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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 Ilson, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Cisplatin, Irinotecan and External Beam Radiation Therapy in people with Esophageal Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site 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 1 inclusion and 19 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 25 Jan 2016. 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 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 25 Jan 2016). 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?
Pathologic Complete Response (time frame: 2 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 25 Jan 2016.