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Completed

NCT Number: NCT02964455

Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hui Liu

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed esophageal squamous cell carcinoma
  • Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
  • Eastern Cooperative Oncology Group (ECOG) performance status 1-2
  • Estimated life expectancy of at least 12 weeks
  • Charlson comorbidity index≤4
  • Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
  • Adequate renal function: creatinine grade 0 or 1
  • Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
  • Weight loss≤15% during 6 months prior to diagnosis
  • Forced expiratory volume second≥1L

Exclusion criteria

  • Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
  • Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
  • Contraindication for chemotherapy or radiotherapy
  • Malignant pleural or pericardial effusion
  • Women in pregnancy or lactation period
  • Women who has the probability of pregnancy without contraception
  • Weight loss≥15% during 3 months prior to diagnosis
  • In other clinical trials within 30 days
  • Addicted in drugs or alcohol, AIDS patients
  • Uncontrollable seizure or psychotic patients without self-control ability
  • Severe allergy or idiosyncrasy
  • Not suitable for this study judged by researchers

Treatment and study plan

docetaxel

Drug

5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation

Nedaplatin

Drug

5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation

chest radiation

Radiation

continuous chest radiation at 64 Gy/32f

Primary outcomes

  1. Occurrence of dose limiting toxicity

    Time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)

  2. Maximum tolerated dose

    Time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)

Secondary outcomes

  1. Occurrence and severity of adverse events

    Time frame: From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)

  2. Clinical response rate

    Time frame: 8 weeks after end of combination treatment

  3. Dynamic plasma concentration of docetaxel and nedaplatin

    Time frame: From start of week 1 to the end of combination treatment (6.5 weeks)

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Nov 16, 2016
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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