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

NCT06922279 | Active Not Recruiting

• 1 other identifier: 0001634/24
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Cancer (GC)

Keywords

Gastroesophageal cancer; metastatic gastroesophageal cancer

Outcome Measures

Primary Outcomes (1)

• Disappearance of symptoms

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

  From the week after the treatment up to 12 months after

Secondary Outcomes (2)

• Pain level

  From the week after the treatment up to 12 months after

• Radiotherapy use

  From the week after the treatment up to 12 months after

Study Arms (2)

Standard systemic therapy without RT/SBRT combination

OTHER

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

Drug: Standard systemic therapy (chemotherapy)

Standard systemic therapy with RT/SBRT combination

EXPERIMENTAL

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).

Radiation: Radiation Therapy + standard sistemic therapy (chemoteraphy)

Interventions

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).

Also known as: SBRT

Standard systemic therapy with RT/SBRT combination

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

Also known as: sistemic therapy, No radiation, standard

Standard systemic therapy without RT/SBRT combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Agostino Gemelli IRCSS

Rome, RM, 00168, Italy

Location

MeSH Terms

Interventions

Radiotherapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: November 30, 2024
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: May 11, 2025

Record last verified: 2025-03

Locations

IT (1)