Esophageal CancerPhase 3NCT00686114
Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer
A Phase 3 study testing Paclitaxel, Cisplatin and Tarceva in people with Esophageal Cancer, run by Wenzhou Medical University at 1 site in China.
Trial summary
This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Paclitaxel, Cisplatin and Tarceva
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Dec 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be confirmed Esophageal Carcinoma pathologically
- (EUS)I～IVa, without contraindication for radical radiotherapy
- Subjects haven't been given neither radiotherapy nor chemotherapy before
- Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
- In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
- Subjects should sign for the informed consent
- Subjects should perform good compliance
- Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative.
Who cannot join
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
- Patients who multiple foci esophagus
- Patients who are/were given any other medicine tests currently/in last 4 weeks
- Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
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- Women in status of pregnancy
- Patients who have complications exist as following:
- (1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
1st affliated hospital of Wen Zhou Medical college
Wenzhou, Zhejiang, 325000
Shixiu Wu, M.D., +86057788069372, wushixiu@medmail.com.cn
Xuebang Zhang, M.D., baxuza@126.com
About this study
Official title: Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.
This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.
Read the detailed description
For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.
- Conditions
- Esophageal Cancer
- Being tested
- Paclitaxel, Cisplatin, Tarceva, Radiotherapy
- Keywords
- Esophageal cancer, chemoradiation, radiosensitivity, EGFR inhibition
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
135mg/m2, day 1 and day 29 of the radiotherapy.
CisplatinDrug
20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy.
TarcevaDrug
Also called Erlotinib Hydrochloride Tablets
150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy)
RadiotherapyRadiation
Enlarged field radiotherapy
RadiotherapyRadiation
Conventional field radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Enlarged field + Paclitaxel + Cisplatin + Tarceva Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Tarceva; Radiation: Radiotherapy |
| B | Experimental | Enlarged field + Paclitaxel + Cisplatin Receives: Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy |
| C | Active comparator | Conventional field + Paclitaxel + Cisplatin + Tarceva Receives: Drug: Paclitaxel; Drug: Cisplatin; Drug: Tarceva; Radiation: Radiotherapy |
| D | Active comparator | Conventional field + Paclitaxel + Cisplatin Receives: Drug: Paclitaxel; Drug: Cisplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
failure: death from any cause
Measured: five years after enrollment
Secondary outcomes (4)
Progression-free survival
Failure: occurrence of local or regional progression, distant metastases, or death from any cause
Measured: five years after enrollment
local-regional control rate
Failure: occurrence of local or regional progression
Measured: three years after enrollment
Adverse events
assessed by RTOG Acute Radiation Morbidity Scoring Criteria and RTOG/EORTC Late Radiation Morbidity Scoring Schema
Measured: five years after enrollment
Health-related quality of life
assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)
Measured: five years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Shixiu, Wenzhou Medical University
- Investigators
- Shixiu Wu, MD, Principal investigator, 1st affliated hospital of Wen Zhou Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686114
- Sponsor's protocol ID
- Shixiu - 1
- Status last verified
- Apr 2014
- First submitted
- 27 May 2008
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xie C, Jing Z, Luo H, Jiang W, Ma L, Hu W, Zheng A, Li D, Ding L, Zhang H, Xie C, Lian X, Du D, Chen M, Bian X, Tan B, Xia B, Xie R, Liu Q, Wang L, Wu S. Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial. Br J Cancer. 2020 Nov;123(11):1616-1624. doi: 10.1038/s41416-020-01054-6. Epub 2020 Sep 22.
PubMed 32958820
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.
- ClinicalTrials.gov ID
- NCT00686114
- Acronym / sponsor ID
- Shixiu - 1
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, chemoradiation, radiosensitivity, EGFR inhibition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 29 May 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.
This study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.
Detailed description
For the esophageal carcinoma in II~III stage, routine dosage of Paclitaxel and platinum medicine chemotherapy concurrently radical radiotherapy is worthy to be studied. On this base, we advanced approach the enlarged field radiotherapy and the intervention of Tarceva. And we approach the therapeutic effect for this method theoretically, which may give a further reasonable guidance for the clinical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Paclitaxel, Drug: Cisplatin, Drug: Tarceva, Radiation: RadiotherapyEnlarged field + Paclitaxel + Cisplatin + Tarceva |
| B | Experimental | Drug: Paclitaxel, Drug: Cisplatin, Radiation: RadiotherapyEnlarged field + Paclitaxel + Cisplatin |
| C | Active comparator | Drug: Paclitaxel, Drug: Cisplatin, Drug: Tarceva, Radiation: RadiotherapyConventional field + Paclitaxel + Cisplatin + Tarceva |
| D | Active comparator | Drug: Paclitaxel, Drug: Cisplatin, Radiation: RadiotherapyConventional field + Paclitaxel + Cisplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must be confirmed Esophageal Carcinoma pathologically
- (EUS)I～IVa, without contraindication for radical radiotherapy
- Subjects haven't been given neither radiotherapy nor chemotherapy before
- Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months
- In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
Key exclusion criteria (9 listed)
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
- Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
- Patients who multiple foci esophagus
- Patients who are/were given any other medicine tests currently/in last 4 weeks
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 |
|---|---|---|
| Paclitaxel135mg/m2, day 1 and day 29 of the radiotherapy. | Drug | A, B, C, D |
| Cisplatin20mg/m2, days 1-3,days 29-31 from the beginning of radiotherapy. | Drug | A, B, C, D |
| TarcevaAlso: Erlotinib Hydrochloride Tablets150mg/day,oral administration, from day 1 to day 42 (at the beginning of therapy) | Drug | A, C |
| RadiotherapyEnlarged field radiotherapy | Radiation | A, B |
| RadiotherapyConventional field radiotherapy | Radiation | C, D |
Primary outcome
overall survival
Time frame: five years after enrollment
failure: death from any cause
4 secondary outcomes
Progression-free survival
Time frame: five years after enrollment
local-regional control rate
Time frame: three years after enrollment
Adverse events
Time frame: five years after enrollment
Health-related quality of life
Time frame: five years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
- Derived from this study: PubMed 32958820Xie C, Jing Z, Luo H, Jiang W, Ma L, Hu W, Zheng A, Li D, Ding L, Zhang H, Xie C, Lian X, Du D, Chen M, Bian X, Tan B, Xia B, Xie R, Liu Q, Wang L, Wu S. Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial. Br J Cancer. 2020 Nov;123(11):1616-1624. doi: 10.1038/s41416-020-01054-6. Epub 2020 Sep 22.
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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.
Shixiu Wu, MD principal investigator
1st affliated hospital of Wen Zhou Medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel, Cisplatin and Tarceva in people with Esophageal Cancer, run by Wenzhou Medical University 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 8 inclusion and 9 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 29 Apr 2014. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shixiu Wu, MD (86-0577-8806-9372, wushixiu@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: five years after enrollment). 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 NCT00686114, 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 29 Apr 2014.