Esophageal CancerNCT03082586

Radiation Dose Escalation in Esophageal Cancer

A study testing radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3 in people with Esophageal Cancer, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this trial is to find the maximum tolerable dose of radiation that can be delivered combined with chemotherapy (DDP \& Paclitaxel) in patients with inoperable or medically unresectable 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?: radiochemotherapy 1, radiochemotherapy 2 and radiochemotherapy 3
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteChina
Study dates: 20 Nov 2016to 20 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Patients with distant metastasis and life expectancy >/= 3 months are eligible.
Zubrod performance status 0 to 2
No prior radiation to the thorax that would overlap with the current treatment field.

Show all 9Show fewer

Patients with nodal involvement are eligible
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. 1 0. Induction chemotherapy is allowed.

Who cannot join

The presence of a fistula.
Prior radiotherapy that would overlap the radiation fields.
gastroesophageal junction cancer.
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

the Ethic Committee of Shanghai General Hospital
Shanghai, Shanghai Municipality, 210000

Other trials in China

About this study

Official title: Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer

Read the detailed description

The RTOG 8501 has established concurrent radiochemotherapy as the standard of care for cancer of the esophagus.However, locoregional remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. New regimen is urgently needed for improving localregional control and survival.

Conditions: Esophageal Cancer
Being tested: radiochemotherapy 1, radiochemotherapy 2, radiochemotherapy 3, radiochemotherapy 4, radiochemotherapy 5
Medical subject headings: Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

radiochemotherapy 1Radiation
Also called concurrent chemoradiotherapy regimen
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
radiochemotherapy 2Radiation
Also called concurrent chemoradiotherapy regimen
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
radiochemotherapy 3Radiation
Also called concurrent chemoradiotherapy regimen
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
radiochemotherapy 4Radiation
Also called concurrent chemoradiotherapy regimen
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
radiochemotherapy 5Radiation
Also called concurrent chemoradiotherapy regimen
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
radiochemotherapy 6Radiation
Also called concurrent chemoradiotherapy regimen
concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly

Study groups in NCT03082586
Study group	Role	What they receive
radiochemotherapy 1	Experimental	Patients will be treated with radiation therapy 57.2 Gy. Receives: Radiation: radiochemotherapy 1
radiochemotherapy 2	Experimental	Patients will be treated with radiation therapy 64.4 Gy. Receives: Radiation: radiochemotherapy 2
radiochemotherapy 3	Experimental	Patients will be treated with radiation therapy 71.6 Gy. Receives: Radiation: radiochemotherapy 3
radiochemotherapy 4	Experimental	Patients will be treated with radiation therapy 78.8 Gy. Receives: Radiation: radiochemotherapy 4
radiochemotherapy 5	Experimental	Patients will be treated with radiation therapy 86 Gy. Receives: Radiation: radiochemotherapy 5
radiochemotherapy 6	Experimental	Patients will be treated with radiation therapy 93.2 Gy. Receives: Radiation: radiochemotherapy 6

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Dose Limiting Toxicities (DLTs) Occurring in Participants
The DLTs were defined as grade >/=4 esophatitis, any other grade >/=3 nonhematological toxicity (except nausea and vomiting), or grade >/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.
Measured: 15 months

Secondary outcomes (1)

Local Failure
Local failure will be assessed radiographically using endoscopy with biopsy, CT scan, and a positron emission computed tomography-CT scan. which was defined as persistence /recurrence of the tumor in the radiation therapy field.
Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201620 Feb 2018

First posted17 Mar 2017
Study start20 Nov 2016
Primary completion20 Feb 2018
Study completion20 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03082586
Sponsor's protocol ID: SGH201705
Status last verified: Jun 2020
First submitted: 13 Mar 2017
Last updated: 22 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cooper 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
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 1584260

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer

All Esophageal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial of Radiation Dose Escalation With Concurrent Weekly Cisplatin and Paclitaxel in Patients With Esophageal Cancer
ClinicalTrials.gov ID: NCT03082586
Acronym / sponsor ID: SGH201705
Conditions: Esophageal Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 20 Nov 2016 (actual)
Primary completion: 20 Feb 2018 (actual)
Study completion: 20 Feb 2018 (actual)
First posted: 17 Mar 2017 (actual)
Results: Posted 7 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
radiochemotherapy 1	Experimental	Radiation: radiochemotherapy 1Patients will be treated with radiation therapy 57.2 Gy.
radiochemotherapy 2	Experimental	Radiation: radiochemotherapy 2Patients will be treated with radiation therapy 64.4 Gy.
radiochemotherapy 3	Experimental	Radiation: radiochemotherapy 3Patients will be treated with radiation therapy 71.6 Gy.
radiochemotherapy 4	Experimental	Radiation: radiochemotherapy 4Patients will be treated with radiation therapy 78.8 Gy.
radiochemotherapy 5	Experimental	Radiation: radiochemotherapy 5Patients will be treated with radiation therapy 86 Gy.
radiochemotherapy 6	Experimental	Radiation: radiochemotherapy 6Patients will be treated with radiation therapy 93.2 Gy.

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.
Patients with distant metastasis and life expectancy >/= 3 months are eligible.
Zubrod performance status 0 to 2

Key exclusion criteria (8 listed)

The presence of a fistula.
Prior radiotherapy that would overlap the radiation fields.
gastroesophageal junction cancer.
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
radiochemotherapy 1Also: concurrent chemoradiotherapy regimenconcurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly	Radiation	radiochemotherapy 1
radiochemotherapy 2Also: concurrent chemoradiotherapy regimenconcurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly	Radiation	radiochemotherapy 2
radiochemotherapy 3Also: concurrent chemoradiotherapy regimenconcurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly	Radiation	radiochemotherapy 3
radiochemotherapy 4Also: concurrent chemoradiotherapy regimenconcurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly	Radiation	radiochemotherapy 4
radiochemotherapy 5Also: concurrent chemoradiotherapy regimenconcurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;	Radiation	radiochemotherapy 5
radiochemotherapy 6Also: concurrent chemoradiotherapy regimenconcurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly	Radiation	radiochemotherapy 6

Primary outcome

Number of Dose Limiting Toxicities (DLTs) Occurring in Participants
Time frame: 15 months
The DLTs were defined as grade >/=4 esophatitis, any other grade >/=3 nonhematological toxicity (except nausea and vomiting), or grade >/=4 hematological toxicity lasting more than 7 days, which are possibly, probably, or definitely associated with protocol treatment occurring during and after completion of the HFRT boost treatment.

1 secondary outcome

Local Failure
Time frame: 15 months

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Radiochemotherapy 1	3	3
Radiochemotherapy 2	3	3
Radiochemotherapy 3	3	3
Radiochemotherapy 4	6	6
Radiochemotherapy 5	13	13
Radiochemotherapy 6	3	3

Primary outcome: Number of Dose Limiting Toxicities (DLTs) Occurring in Participants

Time frame: 15 months. Number. Unit: dose limiting toxicity

Measure	Arm 1: Radiochemotherapy 1 n = 3	Arm 2: Radiochemotherapy 2 n = 3	Arm 3：Radiochemotherapy 3 n = 3	Arm 4: Radiochemotherapy 4 n = 6	Arm 5: Radiochemotherapy 5 n = 13	Arm 6: Radiochemotherapy 6 n = 3
Value	0	0	0	1	0	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Radiochemotherapy 1	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Arm 2: Radiochemotherapy 2	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Arm 3: Radiochemotherapy 3	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Arm 4: Radiochemotherapy 4	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Arm 5: Radiochemotherapy	0 of 13 (0%)	11 of 13 (84.6%)	0 of 13
Arm 6: Radiochemotherapy 6	2 of 3 (66.7%)	1 of 3 (33.3%)	1 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: 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.
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.
Individual participant dataSharing planned: No

Related trials for Esophageal Cancer

RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
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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 principal investigator

the ethic committee of shanghai genernal hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 22 Dec 2020. 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?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Dose Limiting Toxicities (DLTs) Occurring in Participants (time frame: 15 months). 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 NCT03082586, 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 22 Dec 2020.