Paclitaxel/Cisplatin/Fluorouracil Followed by Paclitaxel/Cisplatin/Radiotherapy and Esophagectomy for Esophageal Cancer

A Phase II Study With One-cycle Weekly TP-HDFL Followed by Twice Weekly TP-CCRT and Esophagectomy for Locally Advanced Esophageal Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034332

Enrollment

Registered

2009-12-17

Start date

2007-12-31

Completion date

2009-12-31

Last updated

2009-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

Esophageal cancer, Esophagectomy, Paclitaxel, Induction chemotherapy

Brief summary

We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.

Detailed description

We hypothesize that one-cycle induction chemotherapy may also help to identify chemo-responsive esophageal cancer patients who are highly treatable by definitive CCRT.in order to test this hypothesis, we thus propose this phase II clinical study to verify the role of response to one-cycle induction chemotherapyin the prediction of pathologic complete response rate to CCRT and tje outcomes for patients with loco-regional esophageal cancer.

Interventions

PROCEDURETP-HDFL,TP-CCRT, Esophagectomy

To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT) in patients with locally advanced esophageal cancer.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pathologically proven esophageal cancer * Locally advanced diseases T3 N0-1 M0; T1-3 N1 M0; T1-3 or N0-1 M1a * Age ≥ 18 years old * ECOG ≤ 2 * Creatinine \< 1.5 mg/dl AST, ALT \< 2.5 x upper normal limits Bilirubin \< 2.0 mg/dl * WBC \> 4,000/μl or ANC\>2,000/μl * Platelet \> 100,000//μl * Informed consent

Exclusion criteria

* Invasion to surrounding organs (T4 disease) * Distant mets (except M1a) * Prior thoracic irradiation * Presence of other squamous cell carcinoma of aerodigestive way * Symptomatic co-morbid diseases * Previous malignancy

Design outcomes

Primary

Measure	Time frame
To determine whether clinical response to one cycle of induction chemotherapy (TP-HDFL) could predict the pathologic complete response to preoperative chemoradiotherapy (TP-CCRT	2 years

Countries

Taiwan

Contacts

Primary ContactChih-Hung Hsu, M.D

chihhunghsu@ntu.edu.tw886-2-23711174

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026