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NCT Number: NCT06922279

First Line gastroeSOphageal metastatiC canceR primAry and disTant (if Oligometastatic) lEsions-directed Radiotherapy, a Multicentric, Phase III, Randomized Controlled Trial

The aim of the study is to evaluate the efficacy of radiotherapy on the primary site of gastroesophageal cancer and extracranial stereotactic radiotherapy on metastases before the use of standard systemic therapy, in cases of limited disease burden (in the experimental group), compared to the standard group, which does not receive radiotherapy. This prospective, multicenter, randomized trial aims to evaluate the efficacy of the unconventional approach versus the conventional one in increasing the percentage of asymptomatic patients due to the direct effect of the primary tumor or metastases. "Randomized" means that the assignment to one of the treatment groups mentioned above will be random, not influenced by the physician or the patient's condition. Therefore, your participation in either of the two treatments under study will be assigned randomly and not predetermined. This randomness is crucial for a proper analysis of the results at the end of the study, which will help clarify whether there are differences between the two proposed treatments. This also means that you may not receive direct benefits from participating in this study, as it is a research study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastroesophageal Cancer (GC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with gastroesophageal cancer (i.e.: esophagus, gastroesophageal junction, stomach), for both major squamous cell (SCC) and adenocarcinomatous (ADK) histologies, metastatic, candidate for first-line standard systemic treatment; either newly diagnosed in metastatic stage or first progression to metastasis.
  • Obtaining informed consent.
  • Patients >18 years of age
  • ECOG 0-2
  • Performance of imaging (CT with mdc, MRI with mdc, CT-PET with appropriate tracer) adequate for baseline local and systemic staging and likely to be similarly repeatable at 6 and 12 months after randomization
  • Confirmation at the time of randomization, by the Radiation Therapy Center, that all potentially planned treatments can be performed for the patient (if enrolled in experimental arm) within a maximum of 25 days total before referral to the Medical Oncology Center for systemic therapy

Exclusion criteria

  • Metastatic picture of line following the first
  • Technical or organizational inability to the eventual deadline for radiation treatments within 25 days of randomization
  • Inability to express independent consent to treatments
  • Pregnancy
  • Patient in hospice or with prognosis < 6 months
  • Predicted unavailability for follow-up at 6 months
  • Absence of adequate or likely non-repeatable pretreatment imaging study at 6 and 12 months
  • Previous radiation therapy
  • Previous radiometabolic therapy
  • Inability to maintain treatment position for SBRT
  • Symptomatic emergent or other presentation precluding study development as planned (e.g., epidural compression of the spinal cord or cauda equina)
  • Previous chemotherapy, immunotherapy or target therapy

Treatment and study plan

Radiation Therapy + standard sistemic therapy (chemoteraphy)

Radiation

Standard systemic therapy (chemotherapy treatment with carboplatin-taxol or with drugs that the oncologist considers most useful) + combination of RT on the primary gastroesophageal Gross Tumor Volume (GTV) + SBRT on each of the distal lesions for oligometastatic or limited metastatic spread patients (to be delivered prior to initiation of systemic therapy).

Other names: SBRT

Standard systemic therapy (chemotherapy)

Drug

The patients will go to standard therapy (chemotherapy treatment with carboplatin-taxol or with drugs that the oncologist that the oncologist considers most useful.) without RT/SBRT combination

Other names: sistemic therapy, No radiation, standard

Primary outcomes

  1. Disappearance of symptoms

    Time frame: From the week after the treatment up to 12 months after

    Percentage difference in the rate of patients with symptom (from primary tumor or metastasis) developed within the first 6 months.

Secondary outcomes

  1. Pain level

    Time frame: From the week after the treatment up to 12 months after

    Level of metastasis-associated or primary pain (presence/absence, level and response) at 6 months

  2. Radiotherapy use

    Time frame: From the week after the treatment up to 12 months after

    Rate of recourse to Radiotherapy for pain, obstruction, bleeding or other symptom referable to the primary at 6 months from randomization (and not present at randomization)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: SOCRATE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 10, 2025
Registry last updated
May 11, 2025

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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