Pulmonary NeoplasmPhase 2NCT00128037
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)
A Phase 2 study testing mitomycin C, vindesine, cisplatin and radiotherapy in people with Pulmonary Neoplasm, run by Japan Clinical Oncology Group at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors. Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Pulmonary Neoplasm
- What is being tested?
- mitomycin C, vindesine, cisplatin and radiotherapy
- How many people
- 75 participants
- Where
- 1 siteJapan
- Study dates
- May 1999to Feb 2006
- 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 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
- Invasion to the first rib or more superior chest wall
- Age: 15-74 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Ample organ function
- No prior chemo- or radiotherapy
- Signed informed consent
Who cannot join
- Metastasis to, or involvement of, mediastinal node (N2)
- Distant metastasis or dissemination to pleura/pericardium
- Active concomitant malignancy
- Unstable angina, recent myocardial infarction, heart failure
- Uncontrolled diabetes or hypertension
- Pregnant or lactating women
- Other severe complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors: Initial Report of Japan Clinical Oncology Group Trial (JCOG 9806)
The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.
Read the detailed description
Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.
- Conditions
- Pulmonary Neoplasm
- Being tested
- mitomycin C, vindesine, cisplatin and radiotherapy
- Keywords
- pulmonary neoplasm, preoperative chemoradiotherapy, surgical resection, superior sulcus tumor, chest wall invasion, mytomicin C, vindesine, cisplatin
- Medical subject headings
- Lung Neoplasms, Pancoast Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitomycin C, vindesine, cisplatin and radiotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year survival rate
Secondary outcomes (3)
complete resection rate
post-surgical morbidity/mortality
local control rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startMay 1999
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary NeoplasmStudies 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
- 75 participants
Sponsor and investigators
- Lead sponsor
- Japan Clinical Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Investigators
- Harubumi Kato, M.D., Ph.D., Study chair, Tokyo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128037
- Sponsor's protocol ID
- JCOG 9806
- Other IDs
- C000000031
- Status last verified
- Sep 2016
- First submitted
- 8 Aug 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors: Initial Report of Japan Clinical Oncology Group Trial (JCOG 9806)
- ClinicalTrials.gov ID
- NCT00128037
- Acronym / sponsor ID
- JCOG 9806
- Conditions
- Pulmonary Neoplasm
- Keywords
- pulmonary neoplasm, preoperative chemoradiotherapy, surgical resection, superior sulcus tumor, chest wall invasion, mytomicin C, vindesine, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- May 1999
- Study completion
- Feb 2006
- First posted
- 9 Aug 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 evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.
Detailed description
Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
- Invasion to the first rib or more superior chest wall
- Age: 15-74 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Ample organ function
Key exclusion criteria (7 listed)
- Metastasis to, or involvement of, mediastinal node (N2)
- Distant metastasis or dissemination to pleura/pericardium
- Active concomitant malignancy
- Unstable angina, recent myocardial infarction, heart failure
- Uncontrolled diabetes or hypertension
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 |
|---|---|---|
| mitomycin C, vindesine, cisplatin and radiotherapy | Drug | – |
Primary outcome
3-year survival rate
3 secondary outcomes
complete resection rate
post-surgical morbidity/mortality
local control rate
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 22 Sep 2016.
- Related InfoLink 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.
Harubumi Kato, M.D., Ph.D. study chair
Tokyo Medical University
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 mitomycin C, vindesine, cisplatin and radiotherapy in people with Pulmonary Neoplasm, run by Japan Clinical Oncology Group 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 7 inclusion and 7 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 22 Sep 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 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?
3-year survival rate. 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 22 Sep 2016.