Comparing Paclitaxel/Cisplatin and Cisplatin/5-fluorouracil in Neo-CRT for ESCC

NCT03623737 | Unknown Phase 2

• 1 other identifier: 201606102MIPB
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial has two stages: phase II and phase III. Eligible patients will be randomized 1:1 to the two arms: paclitaxel plus cisplatin and cisplatin plus 5-fluorouracil. The phase II stage will enroll 128 patients, 64 patients for each arm. The endpoint of the phase II stage is complete pathological response (pCR). If the endpoint, i.e., the significant improvement of pCR rate, is met, the clinical trial will proceed to the phase III stage, in which 120 more patients will be enrolled. The estimated enrollment time is four years with 3 more years of follow-up after completing enrollment. The primary endpoint of the clinical trial is overall survival, and the secondary endpoints include clinical response, disease free survival, operation rate, complete resection rate, tumor regression rate, hospital stay days after surgery, safety and toxicity, and quality of life.

Conditions

Esophageal Squamous Cell Carcinoma; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• pathological complete response

  No cancer cells in primary tumor and all lymph nodes resected are observed by pathologists

  2 years

Secondary Outcomes (8)

• Overall survival

  4 years

• disease free survival

  4 years

• clinical response

  2 years

• operation rate

  2 years

• R0 resection rate

  2 years

Study Arms (2)

paclitaxel plus cisplatin

EXPERIMENTAL

A. T: Paclitaxel 50 mg/m2, 1h IVF, weekly, week 1 to week 5 during CRT. B. P: Cisplatin 30 mg/m2, 2 h IVF, weekly following paclitaxel, week 1 to week 5 during CRT.

Drug: neoadjuvant chemoradiation

cisplatin plus 5-fluorouracil

ACTIVE COMPARATOR

A. P: Cisplatin 75 mg/m2, 2 h IVF, on day 1 of week 1 and week 5 during CRT. B. F: 5-FU 1,000 mg/m2, 24 h IVF, on day 1, 2, 3, 4 of week 1 and week 5 during CRT.

Drug: neoadjuvant chemoradiation

Interventions

neoadjuvant chemoradiation DRUG

Neoadjuvant chemoradiation: 1. Radiation: 180cGy/fraction, once daily, 5 days a week, to a total of 4,500cGy. 2. Chemotherapy: Arm A or Arm B Surgery: esophagectomy and 3-fields lymph node dissection

Also known as: esophagectomy

cisplatin plus 5-fluorouracil; paclitaxel plus cisplatin

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically proven squamous cell carcinoma of the intrathoracic esophagus.
• Locally advanced disease, which is defined by the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (7th edition), fulfilling one of the following criteria as determined by endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
• A. T3/4a, N0, M0; B. T1-3, N1-3, M0;
• Tumor length longitudinal ≤ 8cm and radial ≤ 5cm.
• The tumor must not extend more than 2cm into the stomach.
• The tumor must not involve cervical esophagus.
• No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula.
• Age ≥ 20 and ≤ 75 years old.
• Performance status ECOG 0\~2.
• Adequate bone marrow reserves, defined as:
• A. white blood cells (WBC) ≥ 4,000/µl or neutrophil count (ANC) ≥ 2,000/µl; B. platelets ≥ 100,000/µl.
• Adequate liver function reserves, defined as:
• A. hepatic transaminases ≤ 2.5 x upper limit of normal (ULN); B. serum total bilirubin ≤ 2.0 x upper limit of normal (ULN).
• Adequate renal function: Creatinine ≤1.5 x upper normal limit or estimated creatinine clearance ≥ 50 ml/min (estimated by Cockcroft-Gault formulation)
• Written informed consent.

You may not qualify if:

• Adenocarcinoma.
• Previous thoracic irradiation.
• Previous systemic chemotherapy
• Synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer.
• Prior malignancy, except for the following:
• A. adequately treated basal cell or squamous cell skin cancer; B. in-situ cervical cancer; C. a "cured" malignancy more than 5 years prior to enrollment.
• Significant co-morbid disease, which prohibits the conduction of chemotherapy, concurrent chemo- radiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders.
• Documented myocardial infarction within the 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients). Patients with a history of significant ventricular arrhythmia requiring medication. Patients with a history of 2nd or 3rd degree heart block.
• Pre-existing motor or sensory neurotoxicity greater than grade 1.
• Patients with prior allergic reactions to drug containing Cremophor, such as teniposide or cyclosporine.
• Weight loss \> 15%.
• Dementia or altered mental status that would prohibit the understanding and completion of informed consent and questionnaires.
• Estimated life expectancy less than 3 months.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Neoadjuvant Therapy; Esophagectomy

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)

Combined Modality Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ta-Chen Huang, MD

CONTACT

+886937817390; e360215@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: August 9, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)