Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed gastroesophageal adenocarcinoma;

R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);

Have a performance status of 0 or 1 on the ECOG Performance Scale;

Age 18-80 years old, both men and women;

Disqualifiers

Have a history of other malignant tumors in the past or at the same time;

Previous upper abdominal surgery (excluding cholecystectomy);

Bleeding, perforation and obstruction requiring emergency surgical treatment;

Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • different thoracic surgical approaches

    Procedure/Surgery

    Right Versus Left Thoracic Surgical Approaches

Treatment groups

236 Participants
are divided into 2 treatment groups
Group A: Right thoracic approachExperimental treatment 1 intervention
Group B: Left thoracic approachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

OS rate

OS is defined as the time from randomization to death due to any cause.

Time frame
5 years

Secondary outcomes

1

DFS rate

DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.

Time frame
3 years
2

pCR rate

PCR is defined as pT0N0M0

Time frame
1 month after resection
3

MPR rate

MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.

Time frame
1 month after resection
4

Operative Complications

Operative Complications

Time frame
perioperative period

Other outcomes

Sponsors and contacts

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