Esophageal Squamous Cell CarcinomaPhase 2/3NCT03600831
Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2/3 study testing Docetaxel plus cisplatin and radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Huai'an First People's Hospital at 4 sites in China.
Trial summary
The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Docetaxel plus cisplatin and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- 4 sitesChina
- Study dates
- 20 Aug 2018to 31 Dec 2023
- Phase
- Phase 2/3
- 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
- biopsy-confirmed esophageal squamous cell carcinoma
- age ≤ 70 years old,
- Karnofsky performance status ≥ 70,
- R0 esophagectomy according to the pathological examination of the resected specimens,
- postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
- Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin <1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1>0.8 L;.
- no previous treatment or severe complications
- Written informed consent
Who cannot join
- previous treatment with chemotherapy or radiotherapy
- greater than 3 months after surgery
- complete esophageal obstruction after surgery, esophageal perforation;
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- pregnant or breast-feeding women；
- patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease；
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- drug addiction, Alcoholism or AIDS;
- uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- with clear chemotherapy drug allergy
- participation in other interventional clinical trials within 30 days;
Trial locations and contacts
4 sites in 1 country.
China4 sites
Chinese Peiple's Liberation Army No.82 Hospital
Huai'an, Jiangsu, 223300
Huai'an second peiple's Hospital
Huai'an, Jiangsu, 223300
Lianshui County Peoples Hospital
Huai'an, Jiangsu, 223300
xuyi peiple's Hospital
Xucheng, Jiangsu, 211700
About this study
Official title: A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Docetaxel plus cisplatin, radiotherapy
- Keywords
- esophageal neoplasma, adjuvant therapy, chemotherapy, radiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel plus cisplatinDrug
cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks
radiotherapyRadiation
radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)
| Study group | Role | What they receive |
|---|---|---|
| concurrent chemoradiotherapy group | Experimental | All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin). Receives: Drug: Docetaxel plus cisplatin; Radiation: radiotherapy |
| radiotherapy group | Active comparator | All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week). Receives: Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。
Measured: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Secondary outcomes (3)
Overall survival (OS)
From the date of randomization until the date of death
Measured: From date of randomization to death from any cause, assessed up to 3 years
treatment-related toxicities
Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0
Measured: From the date of randomization until six months after treatment completion
Quality of life(QOL)
Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months.
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 posted26 Jul 2018
- Study start20 Aug 2018
- Primary completion30 May 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huai'an First People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second People's Hospital of Huai'an, lian shui county People's Hospital, xuyi People's Hospital, Chinese People's Liberation Army No. 82 Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600831
- Sponsor's protocol ID
- huaianzhuweiguo
- Status last verified
- Dec 2023
- First submitted
- 3 Jul 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03600831
- Acronym / sponsor ID
- huaianzhuweiguo
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- esophageal neoplasma, adjuvant therapy, chemotherapy, radiotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Huai'an First People's HospitalUniversity, hospital or other
- Collaborators
- The Second People's Hospital of Huai'an, lian shui county People's Hospital, xuyi People's Hospital, Chinese People's Liberation Army No. 82 Hospital
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Jul 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.
The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concurrent chemoradiotherapy group | Experimental | Drug: Docetaxel plus cisplatin, Radiation: radiotherapyAll patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin). |
| radiotherapy group | Active comparator | Radiation: radiotherapyAll patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- biopsy-confirmed esophageal squamous cell carcinoma
- age ≤ 70 years old,
- Karnofsky performance status ≥ 70,
- R0 esophagectomy according to the pathological examination of the resected specimens,
- postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
Key exclusion criteria (10 listed)
- previous treatment with chemotherapy or radiotherapy
- greater than 3 months after surgery
- complete esophageal obstruction after surgery, esophageal perforation;
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- pregnant or breast-feeding women；
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 |
|---|---|---|
| Docetaxel plus cisplatincisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks | Drug | concurrent chemoradiotherapy group |
| radiotherapyradiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week) | Radiation | concurrent chemoradiotherapy group, radiotherapy group |
Primary outcome
Disease-free survival (DFS)
Time frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。
3 secondary outcomes
Overall survival (OS)
Time frame: From date of randomization to death from any cause, assessed up to 3 years
treatment-related toxicities
Time frame: From the date of randomization until six months after treatment completion
Quality of life(QOL)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Docetaxel plus cisplatin and radiotherapy in people with Esophageal Squamous Cell Carcinoma, run by Huai'an First People's Hospital at 4 sites 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 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: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease-free survival (DFS) (time frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years). 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 9 Jan 2024.