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Esophageal CancerPhase 2NCT03910634

IMRT With Carboplatin Versus IMRT With Carboplatin and Fluorouracil for Eldly Esophageal Cancer Patients

A Phase 2 study testing Fluorouracil, Intensity modulated radiation therapy and carboplatin in people with Esophageal Cancer and Radiotherapy Side Effect, run by Sun Yat-sen University at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high… Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Esophageal Cancer, Radiotherapy Side Effect
What is being tested?
Fluorouracil, Intensity modulated radiation therapy and carboplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
1 siteChina
Study dates
9 Apr 2019to 31 Dec 2021
Phase
Phase 2
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 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age (> 65 years)
  • Histologically confirmed esophageal squamous cell carcinoma, the 8th edition of AJCC stage T3-4NxM0 or TxN1-3M0, without surgical indications after consultation by surgeons.
  • PS score < 2, Chemotherapy risk score is medium and high risk
  • No radical thoracic surgery/chemotherapy/radiotherapy/targeted therapy has been performed in the past.
  • Diseases measurable according to RECIST standards
  • Hematological examination requires Hb (>90g/L), ANC (>2.0 *109/L) and platelet (>100 *109/L). Serum albumin (>3.0g/dL)
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  • Serum creatinine < 1.25 times normal upper limit (UNL), or creatinine clearance rate (>60 ml/min). Total bilirubin < upper limit of normal value
  • Total bilirubin < the upper limit of normal value, AST (SGOT) and ALT (SGPT) < 2.5 times the upper limit of normal value, ALP < 2.5 times the upper limit of normal value (ULN)
  • If exploratory surgery is performed, the patient will recover at least 2 weeks after operation.

Who cannot join

  • Pregnant or lactating women.
  • Patients with fertility without adequate contraceptive measures.
  • Anaphylaxis to 5FU and carboplatin is known.
  • Anaphylaxis known to exist with any drug in the study
  • Other malignant tumors have occurred in the past five years, except cervical carcinoma in situ or non-melanoma skin cancer, which has been properly treated.
  • Discovery of esophageal fistula or risk of esophageal bleeding before treatment
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  • Distant organ metastasis is known
  • Symptomatic peripheral neuropathy, according to NCIC-CTC criteria (> grade 2).
  • Other serious diseases or medical conditions: Myocardial infarction (in the past six months), severe unstable angina pectoris and congestive heart failure have occurred.
  • Severe complications (including intestinal paralysis, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, severe respiratory dysfunction of COPD, cardiac dysfunction of pulmonary heart disease, uncontrolled diabetes mellitus, renal insufficiency and cirrhosis of liver, etc.)
  • Gastrointestinal bleeding requires frequent blood transfusion.
  • It is known to carry human immunodeficiency virus (HIV) or AIDS.
  • Suffering from mental illness
  • The known neuropathy is of grade 2 or higher severity.

Trial locations and contacts

1 site in 1 country.

China1 site

  • SYSU Cancer Center

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: IMRT Combined With Carboplatin Versus IMRT Combined With Carboplatin and Fluorouracil in the Treatment of Locally Advanced Esophageal Cancer in Elderly Patients With High Risk of Chemotherapy: a Randomized Controlled Clinical Study

An open, single-center, randomized controlled phase II clinical trial to compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy

Read the detailed description

Esophageal cancer is one of the most common malignant tumors in China.To compare the efficacy and safety of conformal intensity modulated radiation therapy (IMRT) combined with carboplatin and IMRT combined with carboplatin and 5-FU in elderly patients with locally advanced esophageal squamous cell carcinoma at high risk of chemotherapy.This trial is an open, single-center, randomized controlled phase II clinical trial.

Being tested
Fluorouracil, Intensity modulated radiation therapy, carboplatin
Keywords
Esophageal Cancer, radiotherapy, chemotherapy, Carboplatin
Medical subject headings
Esophageal Neoplasms, Radiation Injuries

What participants receive

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

  • FluorouracilDrug

    Also called 5-FU

    1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks

  • Intensity modulated radiation therapyRadiation

    Also called IMRT

    Radiotherapy for 5-6 weeks，50-60Gy

  • carboplatinDrug

    Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

Study groups in NCT03910634
Study groupRoleWhat they receive
IMRT combined with carboplatinExperimentalIntensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
Receives: Radiation: Intensity modulated radiation therapy; Drug: carboplatin
IMRT combined with carboplatin and fluorouracilPlacebo comparatorIntensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip; Fluorouracil 1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
Receives: Drug: Fluorouracil; Radiation: Intensity modulated radiation therapy; Drug: carboplatin

What is being measured

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

  1. Overall objective response rate

    The proportion of partial and complete remission of tumors

    Measured: up to 24 months

Secondary outcomes (1)

  1. Incidence of toxic and side effects above 3 degrees

    The Incidence of toxic and side effects above 3 degrees in overall patients

    Measured: up to 24 months

Timeline

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

  1. First posted10 Apr 2019
  2. Study start9 Apr 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2021 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03910634
Sponsor's protocol ID
GD-Q201807
Status last verified
Apr 2019
First submitted
8 Apr 2019
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fluorouracil, Intensity modulated radiation therapy and carboplatin in people with Esophageal Cancer and Radiotherapy Side Effect, run by Sun Yat-sen University 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 14 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 10 Apr 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

Overall objective response rate (time frame: up to 24 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 NCT03910634.

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 10 Apr 2019.

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