RT for Adenocarcinoma/Adenosquamous Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Cervical Adenosquamous Carcinoma; Cervical Adenocarcinoma; Radiotherapy

Treatments: Drug: Systemic treatment; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07153952

ATTRACT-Pros

Details and patient eligibility

About

This study aims to establish a prospective cohort of locally advanced cervical adenocarcinoma to provide a better way to monitor its efficacy and provide precise treatment. The key problems to be solved are as follows:

1. Establish an observational prospective cohort of locally advanced ADC and randomly divide patients with residual cervical tumors in the primary site after CCRT into the local treatment group (salvage surgery or supplementary radiotherapy) or the systemic treatment group.
2. Collect cervical biopsy tissues before and after CCRT in patients with residual cervical tumors, explore the genomic characteristics, and predict whether they can benefit from targeted/immunotherapy in the future.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathological diagnosis of cervical adenocarcinoma;
2. Age 18-80 years old;
3. FIGO 2018 stage IB3-IVA;
4. Karnofsky score≥60 points;
5. Complete blood count, and comprehensive metabolic panel meet the conditions for CCRT;
6. No metal implants in the body, and can perform MRI examination;
7. Willing to participate in this study and provide written informed consent.

Exclusion criteria

1. Patients who have received pelvic radiotherapy before;
2. Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
3. Allergy to iodine contrast agent;
4. Participating in other clinical studies that may affect the results of this study (determined by the principal investigator);

f) Serious diseases that may significantly affect compliance with clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment; g) Other situations that the investigator believes are not suitable for participation in this clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: the local treatment group

Experimental group

Treatment:

Radiation: radiotherapy

Group B: the systemic treatment group

Active Comparator group

Treatment:

Drug: Systemic treatment