Esophageal CancerPhase 2NCT00197444
Low-Dose Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum)/5-FU Combined With Radiation for Esophageal Cancer
A Phase 2 study testing CDGP/5-FU combined with radiation and Radiotherapy in people with Esophageal Cancer and Squamous Cell Carcinoma, run by Hamamatsu University at 1 site in Japan.
Trial summary
The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Esophageal Cancer, Squamous Cell Carcinoma
- What is being tested?
- CDGP/5-FU combined with radiation and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2003to Dec 2008
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed cases histologically as squamous cell carcinoma,
- a performance status 0 to 2,
- white blood cells >3,000/microL,
- platelets >100,000/microL,
- serum total bilirubin <2.0 mg/dl,
- serum transaminase <3 times the upper normal limit,
- serum creatinine <1.5 mg/dl,
- creatinine clearance >60 ml/min
Who cannot join
- serious cardiac disease
- prior chemotherapy and radiotherapy
Trial locations and contacts
1 site in 1 country.
Japan1 site
First Department of Medicine, Hamamatsu University School of Medicine
Hamamatsu, 431-3192
About this study
Official title: A Phase II Study of Daily Low-Dose of Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum) and Continuous Infusion of 5-FU Combined With Radiation for the Treatment of Esophageal Cancer
The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma.
Read the detailed description
The tumor stages and disease grades were classified according to the TNM classification (sixth edition) of the International Union against Cancer (UICC). These were determined conventionally by computed tomography (CT) of the neck, chest and abdomen, bone scan, endoscopic ultrasonography (EUS), endoscopy and esophagography.
Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26. Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 1.8-2.0 Gy per fraction. Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin.
Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (UICC, 2002). Toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.
- Conditions
- Esophageal Cancer, Squamous Cell Carcinoma
- Being tested
- CDGP/5-FU combined with radiation, Radiotherapy
- Keywords
- esophageal cancer, Nedaplatin, 5-FU, chemotherapy, radiation, chemoradiotherapy
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDGP/5-FU combined with radiationDrug
Also called Nedaplatin, 5-FU
Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26.
RadiotherapyRadiation
Also called Radiation
Fractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chemoradiotherapy Receives: Drug: CDGP/5-FU combined with radiation; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 3 months
Secondary outcomes (2)
Adverse events
Measured: every 3-6 months
Survival rate
Measured: every 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionSep 2008
- Study completionDec 2008
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.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Investigators
- Satoshi Osawa, M.D., Principal investigator, First Department of Medicine, Hamamatsu University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197444
- Sponsor's protocol ID
- HAMA-M1-C001
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osawa S, Furuta T, Sugimoto K, Kosugi T, Terai T, Yamade M, Takayanagi Y, Nishino M, Hamaya Y, Kodaira C, Yamada T, Iwaizumi M, Takagaki K, Yoshida K, Kanaoka S, Ikuma M. Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma. BMC Cancer. 2009 Nov 22;9:408. doi: 10.1186/1471-2407-9-408.
PubMed 19930599
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Daily Low-Dose of Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum) and Continuous Infusion of 5-FU Combined With Radiation for the Treatment of Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00197444
- Acronym / sponsor ID
- HAMA-M1-C001
- Conditions
- Esophageal Cancer, Squamous Cell Carcinoma
- Keywords
- esophageal cancer, Nedaplatin, 5-FU, chemotherapy, radiation, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (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 clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma.
Detailed description
The tumor stages and disease grades were classified according to the TNM classification (sixth edition) of the International Union against Cancer (UICC). These were determined conventionally by computed tomography (CT) of the neck, chest and abdomen, bone scan, endoscopic ultrasonography (EUS), endoscopy and esophagography.
Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26. Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 1.8-2.0 Gy per fraction. Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin.
Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (UICC, 2002). Toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CDGP/5-FU combined with radiation, Radiation: RadiotherapyChemoradiotherapy |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- newly diagnosed cases histologically as squamous cell carcinoma,
- a performance status 0 to 2,
- white blood cells >3,000/microL,
- platelets >100,000/microL,
- serum total bilirubin <2.0 mg/dl,
Key exclusion criteria (2 listed)
- serious cardiac disease
- prior chemotherapy and radiotherapy
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 |
|---|---|---|
| CDGP/5-FU combined with radiationAlso: Nedaplatin, 5-FULow-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26. | Drug | 1 |
| RadiotherapyAlso: RadiationFractionated external radiotherapy was performed from the first day of chemotherapy and a total dose of 50.4-66 Gy was delivered at the rate of 1.8-2.0 Gy per fraction. | Radiation | 1 |
Primary outcome
Response rate
Time frame: 3 months
2 secondary outcomes
Adverse events
Time frame: every 3-6 months
Survival rate
Time frame: every 3-6 months
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 20 Feb 2009.
- Derived from this study: PubMed 19930599Osawa S, Furuta T, Sugimoto K, Kosugi T, Terai T, Yamade M, Takayanagi Y, Nishino M, Hamaya Y, Kodaira C, Yamada T, Iwaizumi M, Takagaki K, Yoshida K, Kanaoka S, Ikuma M. Prospective study of daily low-dose nedaplatin and continuous 5-fluorouracil infusion combined with radiation for the treatment of esophageal squamous cell carcinoma. BMC Cancer. 2009 Nov 22;9:408. doi: 10.1186/1471-2407-9-408.
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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.
Satoshi Osawa, M.D. principal investigator
First Department of Medicine, Hamamatsu University School of Medicine
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 CDGP/5-FU combined with radiation and Radiotherapy in people with Esophageal Cancer and Squamous Cell Carcinoma, run by Hamamatsu University at 1 site in Japan.
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 2 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 20 Feb 2009. 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 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.
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?
Response rate (time frame: 3 months). 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 NCT00197444, 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 20 Feb 2009.