Esophageal NeoplasmsPhase 3NCT00190554
A Trial of Chemotherapy Before and After Surgery for Stage II,III Esophageal Squamous Cell Carcinoma
A Phase 3 study testing Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 and (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery in people with Esophageal Neoplasms and Carcinoma, Squamous Cell, run by Japan Clinical Oncology Group at 24 sites in Japan.
Trial summary
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Esophageal Neoplasms, Carcinoma, Squamous Cell
- What is being tested?
- Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 and (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery
- How many people
- 330 participants
- Where
- 24 sitesJapan
- Study dates
- May 2000to May 2009
- Phase
- Phase 3
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- histologically proven squamous cell carcinoma of the thoracic esophagus
- pathologic stages IIa, IIb, III except T4
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- no previous history of chemotherapy nor radiotherapy
- an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr
- oral or written informed consent obtained before randomization
Who cannot join
- severe heart diseases
- uncontrollable hyper tension or diabetes mellitus
- severe pulmonary dysfunction
- HBs positive
- active bacterial infection
- synchronous or metachronous (within 5 years) malignancy
- pregnant female
- psychiatric medication
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Japan24 sites
Juntendo University School of Medicine
Bunkyo-ku,Hongo,3-1-3, Tokyo, 113-0033
Tokyo Medical and Dental University Hospital
Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, 260-8670
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045
Hiroshima City Asa Hospital
Hiroshima,Asakitaku,KabeminamiHiroshima,2-1-1, Hiroshima, 731-0293
Tokyo Dental College Ichikawa General Hospital
Ichikawashi,Sugano,5-11-13, Chiba, 2728513
Tokai University School of Medicine
Isehara,Shimokasuya,143, Kanagawa, 259-1193
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577
Kurume University School of Medicine
Kurume,Asahi-machi,67, Fukuoka, 830-0011
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007
National Hospital Organization Tokyo Medical Center
Meguro-ku,Higashigaoka,2-5-1, Tokyo, 152-8902
Toranomon Hospital
Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, 020-8505
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, 951-8520
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, 162-8666
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582
Sizuoka Cancer Center
Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777
Tochigi Cancer Center
Utsunomiya,Yohnan,4-9-13, Tochigi, 320-0834
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815
About this study
Official title: A Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma
Read the detailed description
The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.
- Conditions
- Esophageal Neoplasms, Carcinoma, Squamous Cell
- Being tested
- Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2, (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery
- Keywords
- esophageal cancer, squamous cell carcinoma, esophagectomy, neoadjuvant chemotherapy, esophageal squamous cell carcinoma
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Squamous Cell, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2Drug
(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋SurgeryDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: year
Secondary outcomes (3)
Overall survival
Measured: year
Toxicity of chemotherapy
Measured: year
Operative morbidity
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2000
- Primary completionMay 2004
- Study completionMay 2009
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 NeoplasmsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 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
- Nobutoshi Ando, M.D., Study chair, Tokyo Dental College Ichikawa General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190554
- Sponsor's protocol ID
- JCOG9907
- Other IDs
- C000000223
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K; Japan Esophageal Oncology Group/Japan Clinical Oncology Group. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011 Dec;98(12):1735-41. doi: 10.1002/bjs.7683. Epub 2011 Sep 14.
PubMed 21918956
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 Randomized Controlled Trial of Chemotherapy With 5FU and Cisplatin Before and After Surgery for Stage II,III Squamous Cell Carcinoma of the Thoracic Esophagus:JCOG9907
- ClinicalTrials.gov ID
- NCT00190554
- Acronym / sponsor ID
- JCOG9907
- Conditions
- Esophageal Neoplasms, Carcinoma, Squamous Cell
- Keywords
- esophageal cancer, squamous cell carcinoma, esophagectomy, neoadjuvant chemotherapy, esophageal squamous cell carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 330 participants
- Lead sponsor
- Japan Clinical Oncology GroupUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- May 2000
- Primary completion
- May 2004 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 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.
To determine whether chemotherapy before surgery makes better outcome than chemotherapy after surgery in patients with esophageal squamous cell carcinoma
Detailed description
The previous study JCOG9204 showed that postoperative adjuvant chemotherapy with cisplatin and fluorouracil has a detectable preventive effect on relapse in patients with esophageal squamous cell carcinoma compared with surgery alone.(J Clin Oncol 2003;21:4592-4596) Therefore the standard treatment for stage II and III esophageal cancer is adjuvant chemotherapy after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- histologically proven squamous cell carcinoma of the thoracic esophagus
- pathologic stages IIa, IIb, III except T4
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- no previous history of chemotherapy nor radiotherapy
- an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr
Key exclusion criteria (8 listed)
- severe heart diseases
- uncontrollable hyper tension or diabetes mellitus
- severe pulmonary dysfunction
- HBs positive
- active bacterial infection
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 |
|---|---|---|
| Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 | Drug | – |
| (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery | Drug | – |
Primary outcome
Disease free survival
Time frame: year
3 secondary outcomes
Overall survival
Time frame: year
Toxicity of chemotherapy
Time frame: year
Operative morbidity
Time frame: year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 21918956Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K; Japan Esophageal Oncology Group/Japan Clinical Oncology Group. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011 Dec;98(12):1735-41. doi: 10.1002/bjs.7683. Epub 2011 Sep 14.
- 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.
Nobutoshi Ando, M.D. study chair
Tokyo Dental College Ichikawa General Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery +(Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2 and (Cisplatin 80 mg/㎡+5FU 800mg/㎡×5days)×2＋Surgery in people with Esophageal Neoplasms and Carcinoma, Squamous Cell, run by Japan Clinical Oncology Group at 24 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?
The sponsor lists 6 inclusion and 8 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: stopped early, 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 24 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Disease free survival (time frame: year). 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 NCT00190554, 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 22 Sep 2016.