IMRT With or Without Concurrent Chemotherapy for Esophageal CancerPhase 3NCT03328234
Radiotherapy With or Without Concurrent Chemotherapy for Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-03
A Phase 3 study testing SIB-IMRT, Paclitaxel and Platinum-Based Drug in people with IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer
- What is being tested?
- SIB-IMRT, Paclitaxel and Platinum-Based Drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2022
- 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 ≤ 16
- 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, 100021
Xin Wang, MD, +861013311583220, beryl_wx2000@163.com
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 Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03
The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.
- Being tested
- SIB-IMRT, Paclitaxel, Platinum-Based Drug, Involved Field Irradiation (IFI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIB-IMRTRadiation
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.
PaclitaxelDrug
45-50mg/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
135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Platinum-Based DrugDrug
Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
Involved Field Irradiation (IFI)Other
CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.
| Study group | Role | What they receive |
|---|---|---|
| SIB-IMRT combined chemotherapy with IFI | Experimental | Not described Receives: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug; Other: Involved Field Irradiation (IFI) |
| SIB-IMRT with IFI | Experimental | Not described Receives: Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug; Other: Involved Field Irradiation (IFI) |
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)
Progression-free survival (PFS)
Measured: 1 year
Progression-free survival (PFS)
Measured: 2 year
Progression-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
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 posted1 Nov 2017
- Study start1 Sep 2017
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IMRT With or Without Concurrent Chemotherapy 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zefen Xiao, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328234
- Sponsor's protocol ID
- 3JECROG P-03
- Status last verified
- Dec 2018
- First submitted
- 28 Oct 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Extensive Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P03
- ClinicalTrials.gov ID
- NCT03328234
- Acronym / sponsor ID
- 3JECROG P-03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Nov 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.
The investigators aimed to compare elective nodal irradiation versus involved field irradiation with or without concurrent chemotherapy and the addition of consolidation chemotherapy for patients with extensive lymphatic metastasis of esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIB-IMRT combined chemotherapy with IFI | Experimental | Radiation: SIB-IMRT, Drug: Paclitaxel, Drug: Platinum-Based Drug, Other: Involved Field Irradiation (IFI) |
| SIB-IMRT with IFI | Experimental | Radiation: SIB-IMRT, Drug: Paclitaxel, Drug: Platinum-Based Drug, Other: Involved Field Irradiation (IFI) |
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 ≤ 16
- 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-IMRTPatients 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. | Radiation | SIB-IMRT combined chemotherapy with IFI, SIB-IMRT with IFI |
| Paclitaxel45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks | Drug | SIB-IMRT combined chemotherapy with IFI |
| Platinum-Based DrugNedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks | Drug | SIB-IMRT combined chemotherapy with IFI |
| Paclitaxel135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy | Drug | SIB-IMRT combined chemotherapy with IFI, SIB-IMRT with IFI |
| Platinum-Based DrugNedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy | Drug | SIB-IMRT combined chemotherapy with IFI, SIB-IMRT with IFI |
| Involved Field Irradiation (IFI)CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin. | Other | SIB-IMRT combined chemotherapy with IFI, SIB-IMRT with IFI |
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
Progression-free survival (PFS)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 2 year
Progression-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.
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.
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 IMRT With or Without Concurrent Chemotherapy for Esophageal Cancer, 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. 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?
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.