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Chemoradiotherapy in Unresectable Esophageal Cancer

ConditionsEsophageal CancerChemoradiotherapyAlbumin-bound PaxlitaxelUnresectable Malignant Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18~75 years

Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)

Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences

ECOG PS score: 0~1

Disqualifiers

With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc

Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer

Existing active infection such as active tuberculosis and hepatitis

History of myocardial infarction within the past 6 months or history of ventricular arrhythmia

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiotherapy

    Radiation

    59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.

  • Albumin-Bound Paclitaxel

    Drug

    100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.

  • Cisplatin

    Drug

    25mg/m2 weekly,by intravenous infusion in 5-6 weeks.

Treatment groups

105 Participants
are divided into 1 treatment group
Group A: Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Local control rate

Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields

Time frame
1 year from the start of treatment to tumor recurrence

Secondary outcomes

1

Number of participants with acute toxicities

Acute toxicities are evaluated by NCI-CTC version 5.0

Time frame
10 week, from the start of treatment to 1 month after chemoradiotherapy
2

Objective response rate

Objective Response Rate are evaluated by RECIST 1.1

Time frame
5.5 week
3

Disease Free Survival

The time from treatment to progression or death

Time frame
1 year, 2 year
4

Progression Free Survival

The time from treatment to progression or death

Time frame
1 year, 2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
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