Esophageal NeoplasmsPhase 3NCT03308552
Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02
A Phase 3 study testing SIB-IMRT, Paclitaxel and Platinum-Based Drug in people with Esophageal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- SIB-IMRT, Paclitaxel and Platinum-Based Drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 30 Aug 2021
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age<70
- Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
- A untreated squamous esophageal carcinoma
- Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
- Adequate organ function
- No known history of drug allergy
- Blood routine examination : WBC≥4.0
- hepatic and renal function are normal
Who cannot join
- Age≥ 70 or < 18
- Already received the treatment of chemotherapy or radiotherapy
- Pregnant or lactating females
- Known drug allergy
- Without agreement of informed consent form
- Insufficient hepatorenal function or Blood routine examination
- Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, 100021
Zefen Xiao, MD
About this study
Official title: A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02
This phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.
- Conditions
- Esophageal Neoplasms
- Being tested
- SIB-IMRT, Paclitaxel, Platinum-Based Drug
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB-IMRTRadiation
PTV:50.4Gy/28f, PGTV:59.92Gy/28f
PaclitaxelDrug
45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
Platinum-Based DrugDrug
Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
PaclitaxelDrug
150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
Platinum-Based DrugDrug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| SIB-IMRT combined chemotherapy followed by chemotherapy | Active comparator | SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days. Receives: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug |
| SIB-IMRT Alone followed by chemotherapy | Placebo comparator | SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively. Receives: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival（OS）
Measured: 1 year
Overall survival（OS）
Measured: 2 year
Overall survival（OS）
Measured: 3 year
Secondary outcomes (8)
Progress free survival（PFS）
Measured: 1 year
Progress free survival（PFS）
Measured: 2 year
Progress free survival（PFS）
Measured: 3 year
Local recurrence-free rate（LRFS）
Measured: 1 year
Local recurrence-free rate（LRFS）
Measured: 2 year
Local recurrence-free rate（LRFS）
Measured: 3 year
Completion Rate
the completion rate of each arm
Measured: up to 2 year
Adverse events
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Dec 2017
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2021 (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 NeoplasmsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute
- Responsible party
- Principal investigator, Zefen Xiao, Chinese Academy of Medical Sciences
- Investigators
- Zefen Xiao, MD, Principal investigator, The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308552
- Sponsor's protocol ID
- 3JECROG P-02
- Status last verified
- Dec 2018
- First submitted
- 8 Oct 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y.
PubMed 32962674
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02
- ClinicalTrials.gov ID
- NCT03308552
- Acronym / sponsor ID
- 3JECROG P-02
- Conditions
- Esophageal Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 12 Oct 2017 (actual)
- 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 phase III trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIB-IMRT combined chemotherapy followed by chemotherapy | Active comparator | Radiation: SIB-IMRT, Drug: Paclitaxel, Drug: Platinum-Based DrugSIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively. Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days. |
| SIB-IMRT Alone followed by chemotherapy | Placebo comparator | Radiation: SIB-IMRT, Drug: Paclitaxel, Drug: Platinum-Based DrugSIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age<70
- Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002）
- A untreated squamous esophageal carcinoma
- Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
- Adequate organ function
Key exclusion criteria (7 listed)
- Age≥ 70 or < 18
- Already received the treatment of chemotherapy or radiotherapy
- Pregnant or lactating females
- Known drug allergy
- Without agreement of informed consent form
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 |
|---|---|---|
| SIB-IMRTPTV:50.4Gy/28f, PGTV:59.92Gy/28f | Radiation | SIB-IMRT Alone followed by chemotherapy, SIB-IMRT combined chemotherapy followed by chemotherapy |
| Paclitaxel45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks | Drug | SIB-IMRT combined chemotherapy followed by chemotherapy |
| Platinum-Based DrugNedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks | Drug | SIB-IMRT combined chemotherapy followed by chemotherapy |
| Paclitaxel150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy | Drug | SIB-IMRT Alone followed by chemotherapy, SIB-IMRT combined chemotherapy followed by chemotherapy |
| Platinum-Based DrugNedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy | Drug | SIB-IMRT Alone followed by chemotherapy, SIB-IMRT combined chemotherapy followed by chemotherapy |
Primary outcome
Overall survival（OS）
Time frame: 1 year
Overall survival（OS）
Time frame: 2 year
Overall survival（OS）
Time frame: 3 year
8 secondary outcomes
Progress free survival（PFS）
Time frame: 1 year
Progress free survival（PFS）
Time frame: 2 year
Progress free survival（PFS）
Time frame: 3 year
Local recurrence-free rate（LRFS）
Time frame: 1 year
Local recurrence-free rate（LRFS）
Time frame: 2 year
Local recurrence-free rate（LRFS）
Time frame: 3 year
Completion Rate
Time frame: up to 2 year
Adverse events
Time frame: up to 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Derived from this study: PubMed 32962674Gao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y.
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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.
Zefen Xiao, MD principal investigator
The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
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 SIB-IMRT, Paclitaxel and Platinum-Based Drug in people with Esophageal Neoplasms, run by Chinese Academy of Medical Sciences 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 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: status not confirmed, as of the sponsor's last update on 2 Jan 2019. 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. Some participants in this study may receive a placebo. 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 Xin Wang, MD (+86-13311583220, beryl_wx2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival（OS） (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT03308552, 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 2 Jan 2019.