Esophageal Squamous Cell CarcinomaPhase 2NCT01605305
Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
A Phase 2 study testing FOLFOX6 in people with Esophageal Squamous Cell Carcinoma, run by Fudan University.
Trial summary
The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- FOLFOX6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jan 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
- Presence of at least one index lesion measurable by CT scan or MRI
- 18~75 years
- kps ≥ 70
- Life expectancy of ≥ 3 months
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- ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
- Cr ≤ 1.0×UNL
- TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL
- Signed written informed consent
Who cannot join
- Previous exposure to oxa therapy in one year
- diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
- chronic diarrhea,enteritis,intestine obstruction which are not under control
- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
- peripheral neuropathy ≥ CTCAE 1
- Other serious disease
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- Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
- USE OTHER ANTITUMOR THERAPY
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
About this study
Official title: Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.
Read the detailed description
Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- FOLFOX6
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX6Drug
OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX6 | Experimental | Not described Receives: Drug: FOLFOX6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TPP
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes (1)
OS
Measured: from the first cycle of treatment (day one) to two month after the last cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startSep 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang Jian Hua, Fudan University
- Investigators
- chang j h, post-doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605305
- Sponsor's protocol ID
- FOLFOX6-2008
- Status last verified
- May 2012
- First submitted
- 22 May 2012
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01605305
- Acronym / sponsor ID
- FOLFOX6-2008
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 May 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 is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.
Detailed description
Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOX6 | Experimental | Drug: FOLFOX6 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
- Presence of at least one index lesion measurable by CT scan or MRI
- 18~75 years
- kps ≥ 70
Key exclusion criteria (9 listed)
- Previous exposure to oxa therapy in one year
- diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
- chronic diarrhea,enteritis,intestine obstruction which are not under control
- Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
- peripheral neuropathy ≥ CTCAE 1
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 |
|---|---|---|
| FOLFOX6OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h | Drug | FOLFOX6 |
Primary outcome
TPP
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
1 secondary outcome
OS
Time frame: from the first cycle of treatment (day one) to two month after the last cycle
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 24 May 2012.
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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.
chang j h, post-doctor principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX6 in people with Esophageal Squamous Cell Carcinoma, run by Fudan University.
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 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: finished, as of the sponsor's last update on 24 May 2012. 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?
TPP (time frame: from the first cycle of treatment (day one) to two month after the last cycle). 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 24 May 2012.