Esophageal CancerNCT00766480
Study of Tissue Samples in Predicting How Well Chemotherapy and Radiation Therapy Will Kill Cancer Cells in Patients With Squamous Cell Carcinoma of the Esophagus
A study testing cisplatin, fluorouracil and radiation therapy in people with Esophageal Cancer, run by University of Toyama at 20 sites in Japan.
Trial summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- cisplatin, fluorouracil and radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 20 sitesJapan
- Study dates
- Jan 2007to Mar 2010
- Phase
- Interventional
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the thoracic esophagus
- Stage IIA, IIB, or III (except T4) disease
- Tumor diameter < 8 cm
- No tumor extension to the cervical esophagus or cardia of the stomach
- No multiple and different histological types of cancer
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 4,000/mm³
- Absolute neutrophil count ≥ 2,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- AST and ALT ≤ 100 IU/L
- Total serum bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 1.2 mg/dL
- Creatinine clearance ≥ 60mL/min
- SpO_2 (room air) ≥ 95%
- Not pregnant or nursing
- No abnormal ECG findings requiring treatment
- No interstitial pneumonitis or no pulmonary fibrosis
- No severe complication (e.g., heart failure, renal failure, hepatic failure, or uncontrollable diabetes mellitus)
- No collagen disease (e.g., PSS or dermatomyositis)
- No mental disease
- No active bacterial infection
- No virus infection (i.e., HBV, HCV, PTHA, or HIV)
PRIOR CONCURRENT THERAPY:
- No prior surgery for esophageal cancer
- No prior chemotherapy
- No prior chest radiotherapy
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites, 20 recruiting
- Recruiting
National Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Yasushi Toh, MD, PhD, 81-92-541-3231
- Recruiting
Hiroshima City Asa Hospital
Hiroshima, Hiroshima, 731-0293
Hidenori Mukaida, 81-82-815-5211
- Recruiting
Kagoshima University
Kagoshima, Kagoshima-ken, 890-8520
Shoji Natsugoe, 81-99-275-5361
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Keiko Minashi, 81-4-7133-1111
- Recruiting
Kawasaki Medical School
Kurashiki, Okayama-ken, 701-01
Toshihiro Hirai, 81-86-462-1199
- Recruiting
Kurume University School of Medicine
Kurume, Fukuoka, 830-0011
Toshiaki Tanaka, 81-942-35-3311
- Recruiting
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Michihide Mitsumori, 81-75-751-3417
- Recruiting
Gunma University Graduate School of Medicine
Maebashi, Gunma, 371-8511
Hiroyuki Kuwano, MD, PhD, 81-27-220-8224, hkuwano@med.gunma-u.ac.jp
- Recruiting
Iwate Medical University Hospital
Morioka, Iwate, 020-8505
Kenichiro Ikeda, 81-19-651-5111
- Recruiting
Aichi Cancer Center
Nagoya, Aichi-ken, 464-8681
Shunzo Hatooka, 81-52-762-6111
- Recruiting
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8510
Tatsuo Kanda, MD, 81-25-227-2228
- Recruiting
Niigata Cancer Center Hospital
Niigata, Niigata, 951-8566
Hiroshi Yabusaki, 81-25-266-5111
- Recruiting
Graduate School of Medical Science at the University of Ryukyu
Nishiharacho, Okinawa, 903-0215
Tadashi Nishimaki, 81-98-895-3331
- Recruiting
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
Koushi Oh, 81-798-45-6582
- Recruiting
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, 537-8511
Ryu Ishihara, 81-6-6972-1181
- Recruiting
Kinki University School of Medicine
Sayama, Osaka, 589-8511
Takushi Yasuda, 81-72-366-0221
- Recruiting
Osaka University Graduate School of Medicine
Suita, Osaka, 565-0871
Masaichi Ohira, 81-6-6645-3837
- Recruiting
Mita Hospital at the International University of Health and Welfare
Tokyo, Tokyo, 108-8329
Ken-ichi Mafune, MD, 81-3-3451-8121, mafune@iuhw.ac.jp
- Recruiting
Tokyo Women's Medical University
Tokyo, Tokyo, 162-8666
Tsutomu Nakamura, 81-3-3353-8111
- Recruiting
Toyama University Hospital
Toyama, Toyama, 930-8555
Yutaka Shimada, MD, PhD, 81-76-434-7331
About this study
Official title: An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus.
Read the detailed description
OBJECTIVES:
- To search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample in patients with esophageal squamous cell carcinoma treated with cisplatin, fluorouracil, and concurrent radiotherapy.
- To establish an algorithm for prediction of chemoradiosensitivity in these patients.
OUTLINE: Patients receive 1 of the following treatment regimens:
- Regimen 1: Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed.
- Regimen 2: Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1.
Pre-operative biopsy samples are analyzed by DNA microarray chip to establish an algorithm for prediction of chemoradiosensitivity.
After completion of study therapy, patients are followed at 12 months.
- Conditions
- Esophageal Cancer
- Being tested
- cisplatin, fluorouracil, radiation therapy
- Keywords
- squamous cell carcinoma of the esophagus, stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
Given IV
fluorouracilDrug
Given IV
radiation therapyRadiation
Patients undergo radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Regimen 1 | Experimental | Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed. Receives: Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy |
| Regimen 2 | Experimental | Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1. Receives: Drug: cisplatin; Drug: fluorouracil; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year progression-free survival
1-year local progression-free survival
3-year progression-free survival
3-year overall survival
Complete histological response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toyama
- Sponsor type
- University, hospital or other
- Investigators
- Yutaka Shimada, MD, PhD, Principal investigator, University of Toyama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766480
- Sponsor's protocol ID
- CDR0000615602
- Other IDs
- TOYAMAU-TRIEC0601
- Status last verified
- Jul 2009
- First submitted
- 3 Oct 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
- ClinicalTrials.gov ID
- NCT00766480
- Acronym / sponsor ID
- CDR0000615602
- Conditions
- Esophageal Cancer
- Keywords
- squamous cell carcinoma of the esophagus, stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of ToyamaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (estimated)
- First posted
- 6 Oct 2008 (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.
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the esophagus.
Detailed description
OBJECTIVES:
- To search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample in patients with esophageal squamous cell carcinoma treated with cisplatin, fluorouracil, and concurrent radiotherapy.
- To establish an algorithm for prediction of chemoradiosensitivity in these patients.
OUTLINE: Patients receive 1 of the following treatment regimens:
- Regimen 1: Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed.
- Regimen 2: Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1.
Pre-operative biopsy samples are analyzed by DNA microarray chip to establish an algorithm for prediction of chemoradiosensitivity.
After completion of study therapy, patients are followed at 12 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen 1 | Experimental | Drug: cisplatin, Drug: fluorouracil, Radiation: radiation therapyPatients receive low-dose cisplatin IV on days 1 and 29 and low-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on days 1-4 and 29-32. Patients undergo salvage surgery if needed. |
| Regimen 2 | Experimental | Drug: cisplatin, Drug: fluorouracil, Radiation: radiation therapyPatients receive high-dose cisplatin IV on days 1 and 29 and high-dose fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy and salvage surgery as in regimen 1. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Regimen 1, Regimen 2 |
| fluorouracilGiven IV | Drug | Regimen 1, Regimen 2 |
| radiation therapyPatients undergo radiotherapy | Radiation | Regimen 1, Regimen 2 |
Primary outcome
1-year progression-free survival
1-year local progression-free survival
3-year progression-free survival
3-year overall survival
Complete histological response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Yutaka Shimada, MD, PhD principal investigator
University of Toyama
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cisplatin, fluorouracil and radiation therapy in people with Esophageal Cancer, run by University of Toyama at 20 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year progression-free survival. The study lists 5 primary outcomes in all. 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 26 Aug 2013.