Paclitaxel plus carboplatin: Paclitaxel (45mg/m2) plus carboplatin (AUC=2); five cycles; qw
radiotherapy: Different radiotherapy dose in different groups.
Study summary
So far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx) or the chemoradiotherapy group (50.4Gy/28Fx;Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Eligibility
Sex
ALL
Min age
76 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Indicates no limit on eligibility based on the sex of participants
* The 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study.
* Esophageal squamous cell carcinoma confirmed by pathology
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* Local advanced esophageal squamous cell carcinoma (T2-4N0-1M0-1a, TxN1M0-1a, TxNxM1a, TxNxM1b (M1b only for supraclavicular lymph node metastasis) (AJCC 6th)
* Use of an effective contraceptive for adults to prevent pregnancy
* No severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function
* No immunodeficiency
* ECOG 0-1.
* Life expectancy of more than 3 months.
Exclusion Criteria:
* Total radiotherapy dose cannot reach 61.2Gy/34Fx
* Esophageal perforation, or hematemesis
* History of radiotherapy or chemotherapy for esophageal cancer
* History of surgery within 28 days before Day 1
* History of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years)
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or fertile patients
* Drug addiction,
* alcoholism or AIDS
* Uncontrolled seizures or psychiatric disorders
Primary outcome measure(s)
overall survival difference of definitive radiotherapy and chemoradiotherapy groups — 3-year The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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