AzTrials
AzTrials

Stage II Esophageal CancerPhase 3NCT03708042

A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer

A Phase 3 study testing Definitive Radiochemotherapy and Neoadjuvant Radiochemotherapy in people with Stage II Esophageal Cancer and Stage III Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Definitive Radiochemotherapy and Neoadjuvant Radiochemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
No sites listed yet
Study dates
1 Dec 2018to 1 Dec 2023
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Thoracic esophageal cancer patients or esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 8th ed.
  • Untreated patients who have not received any antitumor therapy
  • Life expectancy >6 months
  • Age: 18-70 years
  • White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/l, hemoglobin ≥90 g/l; normal liver and kidney functions
  • WHO PS(Performance Status): 0-1
  • Patients who understood the study and gave signed informed consent

Who cannot join

  • Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery;
  • Patients who suffered from hemorrhage or complicated hemorrhage;
  • Other uncontrollable patients who are not suitable for surgery;
  • Female patients in pregnancy or lactation;
  • Patients who agree without acknowledgement due to psychic, family or social factors;
  • Patients who suffered from peripheral neuropathy, with CTC grade ≥2;
Show all 10Show fewer
  • Patients who ever suffered from other types of malignant tumor other than esophagus cancer;
  • Patients who have diabetes history over 10 yrs and blood glucose level is not satisfyingly controlled;
  • Patients who suffer from serious malfunction of heart, lung, liver or kidney, hemotopathy, immune system disease or cachexia and therefore can't tolerate chemotherapy or surgery;
  • Others.

Trial locations and contacts

No sites are listed yet.

Dong Qian, PHD & MD contact

+862223341405

qiankeyu1984@126.com

About this study

Official title: A Phase Ⅲ Trial to Compare Efficacy and Safety of Definitive Chemoradiation VS Neoadjuvant Chemoradiation Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Locally Advanced Esophageal Cancer

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase Ⅲ multicenter clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response (CCR) after neoadjuvant radiochemotherapy for resectable locally advanced esophageal cancer.

Read the detailed description
  1. Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant treatment;
  2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
  3. Compare the relationship and consistency between pathological complete response of endoscopic biopsy specimens after neoadjuvant treatment and pathological complete response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection group;
  4. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.
  5. Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper gastrointestinal/chest CT and symptom assessment indicate major response after Neoadjuvant treatment (Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2), 1st/8th/15th/22nd day
Being tested
Definitive Radiochemotherapy, Neoadjuvant Radiochemotherapy
Keywords
Neoadjuvant Chemoradiation, Definitive Chemoradiation, Clinical complete response
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Definitive RadiochemotherapyCombination product

    Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

  • Neoadjuvant RadiochemotherapyCombination product

    Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Study groups in NCT03708042
Study groupRoleWhat they receive
Definitive RadiochemotherapyExperimentalRadiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
Receives: Combination Product: Definitive Radiochemotherapy
Neoadjuvant RadiochemotherapyActive comparatorRadiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
Receives: Combination Product: Neoadjuvant Radiochemotherapy

What is being measured

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

  1. Overall survival

    Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

    Measured: 5 years

Secondary outcomes (3)

  1. Progression-free survival

    Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy

    Measured: 3 years

  2. Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.

    Measured: 5 years

  3. Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer

    In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected.

    Measured: 3 years

Timeline

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

  1. First posted16 Oct 2018
  2. Study start1 Dec 2018 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

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
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03708042
Sponsor's protocol ID
ESO20181012
Status last verified
Oct 2018
First submitted
12 Oct 2018
Last updated
16 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Definitive Radiochemotherapy and Neoadjuvant Radiochemotherapy in people with Stage II Esophageal Cancer and Stage III Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital.

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 7 inclusion and 10 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 16 Oct 2018. 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 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 Dong Qian, PHD & MD (+862223341405, qiankeyu1984@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). 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 NCT03708042.

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 16 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in