Inoperable Esophageal Cancer Stage I-IIIPhase 2NCT01732380
A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
A Phase 2 study testing Raltitrexed, Oxaliplatin and Radiotherapy in people with Inoperable Esophageal Cancer Stage I-III, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial summary
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inoperable Esophageal Cancer Stage I-III
- What is being tested?
- Raltitrexed, Oxaliplatin and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jul 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
- Measurable disease according to RECIST criteria
- Age > 18 years
- WHO performance score < 2
- Estimated life expectancy of > 12 weeks
- Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy
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- Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- Renal function: Cr ≤ 1.25×UNL
- Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
- Documented informed consent to participate in the trial
Who cannot join
- Subjects with distant metastases
- Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Evidence of bleeding diathesis or serious infection
- pregnant or lactating woman
- Patient participation in other studies
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222002
Xiaodong Jiang, Doctor, jxdysy1970@163.com
About this study
Official title: A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
The aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
Read the detailed description
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.
- Conditions
- Inoperable Esophageal Cancer Stage I-III
- Being tested
- Raltitrexed, Oxaliplatin, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltitrexedDrug
Also called TOMUDEX, Sai Wei Jian
OxaliplatinDrug
Also called Eloxatin
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Active comparator | Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer Receives: Radiation: Radiotherapy |
| Raltitrexed/Oxaliplatin Plus Radiotherapy | Experimental | Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer Receives: Drug: Raltitrexed; Drug: Oxaliplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
Measured: up to 2 years
Secondary outcomes (1)
Response Rate
Response rate (RR) is a figure representing the percentage of patients whose cancer shrinks (termed a partial response, PR) or disappears after treatment (termed a complete response, CR) . In simpler terms RR=PR+CR.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inoperable Esophageal Cancer Stage I-IIIStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Collaborators
- The East Hospital of Lianyungang, Donghai People's Hospital, People's Hospital of Ganyu
- Responsible party
- Sponsor
- Investigators
- Xiaodong Jiang, Doctor, Study chair, The First People's Hospital of Lianyungang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732380
- Sponsor's protocol ID
- 1stPeopleLianyungang
- Status last verified
- Nov 2012
- First submitted
- 14 Nov 2012
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Courrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175.
PubMed 20645400Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.
PubMed 17329193McKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14.
PubMed 20839062Seitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183.
PubMed 12176786Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.
PubMed 12075739
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01732380
- Acronym / sponsor ID
- 1stPeopleLianyungang
- Conditions
- Inoperable Esophageal Cancer Stage I-III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Collaborators
- The East Hospital of Lianyungang, Donghai People's Hospital, People's Hospital of Ganyu
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 22 Nov 2012 (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 aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
Detailed description
108 patients were randomized to receive Raltitrexed/Oxaliplatin Plus Radiotherapy (Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks.)or Radiotherapy ( Radiotherapy 2.0Gy/day, 5 times/week,6 weeks) in subjects with Inoperable esophageal cancer. All patients will receive therapy of six weeks unless disease progression or unacceptable toxicity. Patients were evaluated every 3 months .Progression-Free-Survival was the primary endpoint. Response Rate, Overall survival, toxicity of the therapy are other second endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Active comparator | Radiation: RadiotherapyRadiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer |
| Raltitrexed/Oxaliplatin Plus Radiotherapy | Experimental | Drug: Raltitrexed, Drug: Oxaliplatin, Radiation: RadiotherapyRaltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma)
- Measurable disease according to RECIST criteria
- Age > 18 years
- WHO performance score < 2
- Estimated life expectancy of > 12 weeks
Key exclusion criteria (6 listed)
- Subjects with distant metastases
- Pregnancy or breast feeding. Women of childbearing age must use effective contraception
- Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
- Evidence of bleeding diathesis or serious infection
- pregnant or lactating woman
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 |
|---|---|---|
| RaltitrexedAlso: TOMUDEX, Sai Wei Jian | Drug | Raltitrexed/Oxaliplatin Plus Radiotherapy |
| OxaliplatinAlso: Eloxatin | Drug | Raltitrexed/Oxaliplatin Plus Radiotherapy |
| Radiotherapy | Radiation | Radiotherapy, Raltitrexed/Oxaliplatin Plus Radiotherapy |
Primary outcome
Progression-Free-Survival
Time frame: up to 2 years
Progression-free survival (PFS) is the length of time during and after medication or treatment during which the disease being treated (usually cancer) does not get worse.
1 secondary outcome
Response Rate
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
- Background: PubMed 20645400Courrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175.
- Background: PubMed 17329193Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6.
- Background: PubMed 20839062McKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14.
- Background: PubMed 12176786Seitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183.
- Background: PubMed 12075739Cascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091.
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.
Xiaodong Jiang, Doctor study chair
The First People's Hospital of Lianyungang
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 Raltitrexed, Oxaliplatin and Radiotherapy in people with Inoperable Esophageal Cancer Stage I-III, run by The First People's Hospital of Lianyungang at 1 site in China.
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Nov 2012. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Jiang, Doctor (86-0518-85469074, jxdysy1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (time frame: up to 2 years). 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 NCT01732380, which also lists 5 linked publications.
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 Nov 2012.