Esophageal CancerNCT03535207
High-dose Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer
A study testing high dose chemoradiotherapy in people with Esophageal Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- high dose chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 Jun 2022
- Phase
- Interventional
- 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 confirmed primary squamous cell carcinoma of the esophagus
- Age 1 8-75.
- Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
- Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2
- No prior radiation to the thorax that would overlap with the current treatment field.
- Patients with nodal involvement are eligible
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- Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin >/= 10.0 g/dl, Platelet count >/= 1 00,000/ mm^3,absolute granulocyte count (AGC) ≥2 × 10^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine </ =1 .5 times ULN.
- A signed informed consent must be obtained prior to therapy.
- Induction chemotherapy is allowed
Who cannot join
- The presence of a fistula.
- Prior radiotherapy that would overlap the radiation fields.
- gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall.
- Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
- Known hypersensitivity to paclitaxel.
- Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
- Acquired Immune Deficiency Syndrome.
- Conditions precluding medical follow-up and protocol compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Genernal Hospital
Shanghai, Shanghai Municipality, 210000
Ningning Chen, MD, 37798364 ext. 8119, ningcnn@163.com
yong Liu, MD, 37798364, drliuyrt@163.com
About this study
Official title: Phase II Study of High-dose （86 Gy）Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer
Read the detailed description
The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
- Conditions
- Esophageal Cancer
- Being tested
- high dose 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.
high dose chemoradiotherapyRadiation
Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy.
concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy.
Adjuvant chemotherapy after high dose chemoradiation is optional.
| Study group | Role | What they receive |
|---|---|---|
| high dose chemoradiotherapy | Experimental | all eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks，followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy Receives: Radiation: high dose chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival rate
survival time was measured from the date of study enrollment to the date of death or last follow-up
Measured: one year
Secondary outcomes (1)
toxicities
Acute toxicities were graded according to the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 4.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Apr 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen tingfeng, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Tingfeng Chen, MD, Study director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535207
- Sponsor's protocol ID
- SGH201802
- Status last verified
- Mar 2021
- First submitted
- 1 May 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.
PubMed 1584260Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.
PubMed 10235156
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of High-dose （86 Gy）Intensity Modulated Radiotherapy and Concurrent Paclitaxel and Cisplatin in Locoregionally Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03535207
- Acronym / sponsor ID
- SGH201802
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 24 May 2018 (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.
To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locoregionally advanced esophageal cancer
Detailed description
The Radiation Therapy Oncology Group (RTOG) 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional failure remains problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the standard dose (50-50.4 Gy) chemoradiotherapy . Our previous phase I radiation dose escalation trial established the maximum tolerated dose of 86 Gy with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high dose chemoradiotherapy | Experimental | Radiation: high dose chemoradiotherapyall eligible patients receive intensity-modulated radiotherapy 50 Gy in 25 fractions over 5 weeks and concurrent paclitaxel and cisplatin once weekly for 5 weeks，followed by hyperfractionated intensity-modulated radiotherapy boost to gross tumor volume concurrent with the same chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed primary squamous cell carcinoma of the esophagus
- Age 1 8-75.
- Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
- Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2
- No prior radiation to the thorax that would overlap with the current treatment field.
Key exclusion criteria (8 listed)
- The presence of a fistula.
- Prior radiotherapy that would overlap the radiation fields.
- gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall.
- Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
- Known hypersensitivity to paclitaxel.
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 |
|---|---|---|
| high dose chemoradiotherapyRadiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy. concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy. Adjuvant chemotherapy after high dose chemoradiation is optional. | Radiation | high dose chemoradiotherapy |
Primary outcome
overall survival rate
Time frame: one year
survival time was measured from the date of study enrollment to the date of death or last follow-up
1 secondary outcome
toxicities
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 1584260Herskovic A, Martz K, al-Sarraf M, Leichman L, Brindle J, Vaitkevicius V, Cooper J, Byhardt R, Davis L, Emami B. Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus. N Engl J Med. 1992 Jun 11;326(24):1593-8. doi: 10.1056/NEJM199206113262403.
- Results publication: PubMed 10235156Cooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623.
- Individual participant dataSharing planned: No
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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.
Tingfeng Chen, MD study director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high dose chemoradiotherapy in people with Esophageal Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 9 inclusion and 8 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 18 Mar 2021. 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.
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 Ningning Cheng (37798364 ext. 8119, ningcnn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival rate (time frame: one year). 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 NCT03535207, which also lists 2 linked publications.
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 18 Mar 2021.