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NCT Number: NCT03961841

Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

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Key information

Conditions

Esophagogastric Junction Disorder Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consensus of the enrolled patients
  • from 18 to 75 years old
  • proven to be primary adenocarcinoma of EGJ
  • pre-operative staging cT3-4N+M0
  • no prior other chemotherapy and/or radiation against the disease
  • normal function of all other vital organs including heart,liver ,kidney and so on
  • Eastern Cooperative Oncology Group performance status: 0~2

Exclusion criteria

  • history of other malignancy
  • allergic reaction to capecitabine or oxaliplatin
  • enrolled in other clinical trials
  • abnormal GI tract function
  • dysfunction of other organs
  • pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
  • other situations judged as not adaptive to the study by investigators

Treatment and study plan

chemoradiation with weekly 5Fu and oxaliplatin

Radiation

5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week

Perioperative mFLOT

Drug

Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles

Perioperative FOLFOX

Drug

Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles

Primary outcomes

  1. 3 year of disease free survival

    Time frame: 3 year

Secondary outcomes

  1. 5 year of overall survival

    Time frame: 5 year

  2. Rate of pathological complete remission

    Time frame: 1 year

  3. Anastomosis leak rate

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Shanshan Li, MD

CONTACT

[email protected]

86-20-38285497

Xiaohui Zhai, MD

CONTACT

[email protected]

86-20-38285497

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

A Randomised Controlled Trial Comparing Perioperative FLOT, FOLFOX and Preoperative Chemoradiation for Locally Advanced Esophagogastric Junction Adenocarcinoma

Important dates

Study start
2020
Primary completion
2024
Study completion
2029
First posted
May 23, 2019
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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