Esophageal CancerPhase 2NCT02607982
CCRT for Esophageal Cancer.
A Phase 2 study testing Paclitaxel, Oxaliplatin and Radiotherapy in people with Esophageal Cancer and Concurrent Chemoradiotherapy, run by Hangzhou Cancer Hospital.
Trial summary
This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Concurrent Chemoradiotherapy, Oxaliplatin
- What is being tested?
- Paclitaxel, Oxaliplatin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Nov 2015
- 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
- Cytologically or histologically confirmed esophageal carcinoma
- Age of 20 -80
- ECOG performance status: 0-1;
- No treatments prior to enrollment;
- At least one measurable lesion on CT, MRI or esophageal barium exam;
- Normal functions of heart, lung, liver, kidney and bone marrow
- Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
- Informed consent signed
Who cannot join
- Prior treatments of chemotherapy or irradiation;
- Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
- Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
- Participating in other clinical trials;
- Pregnancy, breast feeding, or not adopting birth control;
- Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
- The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
About this study
Official title: Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.
This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.
- Being tested
- Paclitaxel, Oxaliplatin, Radiotherapy
- Keywords
- Esophageal cancer, Concurrent chemoradiotherapy, Oxaliplatin, Paclitaxel, Survival, Toxicity
- 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
PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.
OxaliplatinDrug
oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.
RadiotherapyRadiation
Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Chemoradiotherapy Arm | Experimental | Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy. Receives: Drug: Paclitaxel; Drug: Oxaliplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Response rate was done after 4 weeks following the last radiotherapy session.
Measured: week 4
Secondary outcomes (2)
Survival outcome
Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Measured: year 0- year 5
Toxicity
Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).
Measured: year 0- year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startJan 2005
- Primary completionJun 2014
- Study completionNov 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shixiu Wu, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607982
- Sponsor's protocol ID
- HangzhouCH03
- Status last verified
- Feb 2016
- First submitted
- 16 Nov 2015
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zhang P, Xie CY, Wu SX. [Concurrent chemoradiation with paclitaxel and platinum for locally advanced esophageal cancer]. Zhonghua Zhong Liu Za Zhi. 2007 Oct;29(10):773-7. Chinese.
PubMed 18396692
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT02607982
- Acronym / sponsor ID
- HangzhouCH03
- Keywords
- Esophageal cancer, Concurrent chemoradiotherapy, Oxaliplatin, Paclitaxel, Survival, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hangzhou Cancer HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Nov 2015 (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 aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Chemoradiotherapy Arm | Experimental | Drug: Paclitaxel, Drug: Oxaliplatin, Radiation: RadiotherapyRadiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cytologically or histologically confirmed esophageal carcinoma
- Age of 20 -80
- ECOG performance status: 0-1;
- No treatments prior to enrollment;
- At least one measurable lesion on CT, MRI or esophageal barium exam;
Key exclusion criteria (7 listed)
- Prior treatments of chemotherapy or irradiation;
- Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
- Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
- Participating in other clinical trials;
- Pregnancy, breast feeding, or not adopting birth control;
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 |
|---|---|---|
| PaclitaxelPTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications. | Drug | Concurrent Chemoradiotherapy Arm |
| Oxaliplatinoxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1. | Drug | Concurrent Chemoradiotherapy Arm |
| RadiotherapyRadiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used. | Radiation | Concurrent Chemoradiotherapy Arm |
Primary outcome
response rate
Time frame: week 4
Response rate was done after 4 weeks following the last radiotherapy session.
2 secondary outcomes
Survival outcome
Time frame: year 0- year 5
Toxicity
Time frame: year 0- year 5
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 17 Feb 2016.
- Background: PubMed 18396692Zhang P, Xie CY, Wu SX. [Concurrent chemoradiation with paclitaxel and platinum for locally advanced esophageal cancer]. Zhonghua Zhong Liu Za Zhi. 2007 Oct;29(10):773-7. Chinese.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Oxaliplatin and Radiotherapy in people with Esophageal Cancer and Concurrent Chemoradiotherapy, run by Hangzhou Cancer Hospital.
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 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 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
response rate (time frame: week 4). 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 NCT02607982, 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 17 Feb 2016.