Esophageal CancerPhase 2NCT01463501
Neoadjuvant Versus Adjuvant Therapy in Treating Resectable Thoracic Esophageal Cancer
A Phase 2 study testing Neoadjuvant chemoradiotherapy and Adjuvant chemoradiotherapy in people with Esophageal Cancer, run by Zhejiang Cancer Hospital at 2 sites in China.
Trial summary
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Neoadjuvant chemoradiotherapy and Adjuvant chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2011to Dec 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20cm from the incisors) or gastroesophageal junction are included.
- No distant metastases (M0).
- Patients will be stratified by stage (clinical N0 versus clinical N1).
- Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
- Resectable mediastinal nodes are eligible.
- No prior chemotherapy for this malignancy.
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- No prior radiotherapy that would overlap the field(s) treated in this study.
- Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer.
- Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon.
Who cannot join
- Cancers of the cervical esophagus (< 20 cm are excluded).
- Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
- Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
- Patients with biopsy proven metastatic celiac nodes are ineligible.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Weimin Mao, MD., +86-571-88122032, maowmzj1218@163.com
Yaping Xu, MD, +86-571-88122082, xuyaping1207@gmail.com
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Yaping Xu, MD, +86 0571 88122082, xuyaping1207@gmail.com
About this study
Official title: Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer
This is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
Read the detailed description
Patient Population:
Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0
Scheme:
Patients are randomized to 2 arms:
Arm A:
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Arm B:
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
- Conditions
- Esophageal Cancer
- Being tested
- Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy
- Keywords
- Esophageal cancer, Resectable, Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoradiotherapyOther
Also called Neoadjuvant Treatment
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Adjuvant chemoradiotherapyOther
Also called Adjuvant Treatment
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Treatment | Experimental | Preoperative chemotherapy/radiotherapy Receives: Other: Neoadjuvant chemoradiotherapy |
| Adjuvant Treatment | Experimental | Postoperative chemotherapy/radiotherapy Receives: Other: Adjuvant chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores of Quality of life
Assess the quality of life based on FACT-E.
Measured: 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Assess the safety and tolerability based on NCI CTC V4.0
Measured: 1 year
Secondary outcomes (2)
Disease-free Survival
Three years disease free survival will be evaluated.
Measured: 3 years
Overall Survival
Three years overall survival will be evaluated.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weimin Mao, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463501
- Sponsor's protocol ID
- ZhejiangCH09
- Status last verified
- Sep 2011
- First submitted
- 30 Aug 2011
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and Carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and Carboplatin) for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01463501
- Acronym / sponsor ID
- ZhejiangCH09
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal cancer, Resectable, Neoadjuvant chemoradiotherapy, Adjuvant chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Nov 2011 (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 is a prospective Randomized Phase Ⅱ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
Detailed description
Patient Population:
Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0
Scheme:
Patients are randomized to 2 arms:
Arm A:
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Arm B:
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Treatment | Experimental | Other: Neoadjuvant chemoradiotherapyPreoperative chemotherapy/radiotherapy |
| Adjuvant Treatment | Experimental | Other: Adjuvant chemoradiotherapyPostoperative chemotherapy/radiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20cm from the incisors) or gastroesophageal junction are included.
- No distant metastases (M0).
- Patients will be stratified by stage (clinical N0 versus clinical N1).
- Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy.
- Resectable mediastinal nodes are eligible.
Key exclusion criteria (4 listed)
- Cancers of the cervical esophagus (< 20 cm are excluded).
- Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible.
- Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible.
- Patients with biopsy proven metastatic celiac nodes are ineligible.
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 |
|---|---|---|
| Neoadjuvant chemoradiotherapyAlso: Neoadjuvant TreatmentPaclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles. | Other | Neoadjuvant Treatment |
| Adjuvant chemoradiotherapyAlso: Adjuvant TreatmentSurgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles. | Other | Adjuvant Treatment |
Primary outcome
Scores of Quality of life
Time frame: 1 year
Assess the quality of life based on FACT-E.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 1 year
Assess the safety and tolerability based on NCI CTC V4.0
2 secondary outcomes
Disease-free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
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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.
Weimin Mao, MD principal investigator
Zhejiang Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant chemoradiotherapy and Adjuvant chemoradiotherapy in people with Esophageal Cancer, run by Zhejiang Cancer Hospital at 2 sites 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 9 inclusion and 4 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 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Weimin Mao, MD. (+86-571-88122032, maowmzj1218@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores of Quality of life (time frame: 1 year). The study lists 2 primary outcomes in all. 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 14 May 2013.