Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT02964455 | Completed Phase 1

• 1 other identifier: GASTO201610003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma; Chemoradiotherapy; Docetaxel; Nedaplatin; Twice weekly

Outcome Measures

Primary Outcomes (2)

• Occurrence of dose limiting toxicity

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

• Maximum tolerated dose

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

Secondary Outcomes (3)

• Occurrence and severity of adverse events

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

• Clinical response rate

  8 weeks after end of combination treatment

• Dynamic plasma concentration of docetaxel and nedaplatin

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

Study Arms (1)

Docetaxel + Nedaplatin + Radiotherapy

EXPERIMENTAL

Docetaxel and nedaplatin 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.

Drug: Docetaxel; Drug: Nedaplatin; Radiation: chest radiation

Interventions

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

Docetaxel + Nedaplatin + Radiotherapy

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

Docetaxel + Nedaplatin + Radiotherapy

chest radiation RADIATION

continuous chest radiation at 64 Gy/32f

Docetaxel + Nedaplatin + Radiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Hui Liu

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Docetaxel; nedaplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Hui Liu, Prof.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)