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Status unknownNCT03910634Updated Apr 10, 2019

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

A Phase 2 interventional study of Fluorouracil and Intensity modulated radiation therapy in Esophageal Cancer and Radiotherapy Side Effect, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Esophageal Cancer
  • Radiotherapy Side Effect

Keywords

  • Esophageal Cancer
  • radiotherapy
  • chemotherapy
  • Carboplatin
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 264 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
264 participants (estimated)

Study arms

  • Experimental
    IMRT combined with carboplatin

    Intensity modulated radiation therapy 50-60Gy, Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks

    Radiation: Intensity modulated radiation therapy · Drug: carboplatin

  • Placebo comparator
    IMRT combined with carboplatin and fluorouracil

    Intensity 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

    Drug: Fluorouracil · Radiation: Intensity modulated radiation therapy · Drug: carboplatin

Interventions

  • DrugFluorouracil

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

    Also known as: 5-FU

  • RadiationIntensity modulated radiation therapy

    Radiotherapy for 5-6 weeks，50-60Gy

    Also known as: IMRT

  • Drugcarboplatin

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

06

What researchers measure

Primary outcomes

  1. Overall objective response rate

    The proportion of partial and complete remission of tumors

    Time frame: up to 24 months

Secondary outcomes

  1. Incidence of toxic and side effects above 3 degrees

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

    Time frame: up to 24 months

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Study locations

1 site
  • SYSU Cancer Center
    Guangzhou, Guangdong 510000, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03910634
Lead sponsor
Sun Yat-sen University
Responsible party
Zhu Yujia (Doctor, Sun Yat-sen University) — Principal investigator
First posted
Apr 10, 2019
Start date
Apr 9, 2019 (estimated)
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Apr 10, 2019

Study contacts

Yonghong Hu, Doctor
study director · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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