RT for Adenocarcinoma/Adenosquamous Carcinoma

NCT07153952 | Active Not Recruiting Phase 1

• 1 other identifier: ATTRACT-Pros
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor control rate

  Tumor control rate among patients with residual cervical tumors in the two groups 3 months after treatment

Secondary Outcomes (2)

• progression-free survival

  2-year progression-free survival

• overall survival

  2-year overall survival rate

Study Arms (2)

Group A: the local treatment group

EXPERIMENTAL

Radiation: radiotherapy

Group B: the systemic treatment group

ACTIVE COMPARATOR

Drug: Systemic treatment

Interventions

radiotherapy RADIATION

The surgical method is determined by the gynecological oncologist, including total hysterectomy, pelvic exenteration, or radical total hysterectomy. The specific surgical choice needs to be comprehensively judged based on the patient's residual tumor location, size, and other complications. Supplementary radiotherapy is mainly image-guided brachytherapy ± external irradiation. The irradiation range and dose must be comprehensively considered based on the location and size of the residual lesions. The best local treatment plan is jointly determined by gynecological oncologists and radiotherapists.

Group A: the local treatment group

Systemic treatment DRUG

Systemic treatment regimens include chemotherapy ± targeted therapy ± immunotherapy. According to the NCCN Guidelines (2024.V2), the first-line chemotherapy regimen for persistent, recurrent, or metastatic cervical cancer is preferably carboplatin/paclitaxel and cisplatin/paclitaxel. The addition of immunotherapy can be determined based on the PD-L1 expression level. The specific chemotherapy regimen will be determined by the gynecological oncologist based on the residual tumor site, the number of lesions, and other complications. In addition, if the patient's pathological results indicate HER2 positivity or the genetic test results show PIK3CA mutation, targeted therapy, such as neratinib or apelisimab, can be considered as a second-line regimen after the first-line chemotherapy regimen progresses.

Group B: the systemic treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have received pelvic radiotherapy before;
• Patients whose target tumors have been treated before (chemotherapy, immunotherapy, surgical treatment, etc.);
• Allergy to iodine contrast agent;
• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The First Affiliated Hospital of Xiamen University: collaborator
• Heilongjiang Cancer Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Obstetrics and Gynecology Hospital of Zhejiang University: collaborator
• Luohe Central Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

Radiotherapy; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Combined Modality Therapy

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Assistant for Department of Radiotherapy

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: September 4, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-01

Locations

CN (1)