A Randomized Controlled Trial Evaluating of Prophylactic Irradiation in CRT for cT1bN0M0 ESCC

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cancer Center, Japan

About this trial

This study is conducted to investigate whether modified chemoradiotherapy with elective nodal irradiation reduces the locoregional recurrence that cannot be completely resected by salvage endoscopic resection and preserve esophagus without compromising overall survival.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma.

All lesions located in the thoracic esophagus. Secondary lesions with an absolute indication for endoscopic resection (EMR/ESD) may not be confined to the thoracic esophagus.

Clinical N0M0 with cervical to abdominal contrast-enhanced CT.

The deepest lesion is diagnosed as cT1b (SM1 / SM2 / SM3) with upper gastrointestinal endoscopy. If it is difficult to differentiate cT1a-MM and cT1b-SM1 clinically, the wall depth is diagnosed as cT1b-SM1.

Disqualifiers

Simultaneous or metachronous (within 5 years) double cancers, except for intramucosal tumor curable with local therapy.

Active infection requiring systemic therapy.

Fever over 38 degrees Celsius

Female during pregnancy, within 28 days of post parturition, or during lactation. Male who wants a partner's pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemoradiotherapy

    Radiation

    Chemoradiotherapy

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Chemoradiation therapy with elective nodal irradiationExperimental treatment 1 intervention
Group B: Chemoradiation therapy with involved field irradiationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major progression-free survival

If the remnant lesion in the esophagus or a recurrent lesion after complete response (CR) can be curatively removed by salvage EMR/ESD, it is not an event, and other progressions and deaths are events.

Time frame
The primary analysis will be held 5-years after the last patient was enrolled.

Secondary outcomes

1

Overall survival

From date of randomization to date of death, approximately 5 years.

Time frame
The primary analysis will be held 5-years after the last patient was enrolled.
2

Progression-free survival

From date of randomization to date of progression or death, whichever occurs first, approximately 5 years.

Time frame
The primary analysis will be held 5-years after the last patient was enrolled.
3

Complete response rate

CR was defined as disappeared primary tumors without the presence of ulceration or malignant cells in biopsy specimens under endoscopy.

Time frame
The primary analysis will be held 5-years after the last patient was enrolled.
4

Esophagectomy-free survival

From date of randomization to date of esophagectomy or death, whichever occurs first, approximately 5 years.

Time frame
The primary analysis will be held 5-years after the last patient was enrolled.

Other outcomes

Sponsors and contacts

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