Gastric-type Endocervical AdenocarcinomaPhase 3NCT06870565
Comparative Study of Adjuvant Therapy for Postoperative Cervical Gastric-type Adenocarcinoma
A Phase 3 study testing paclitaxel and platinum and platinum in people with Gastric-type Endocervical Adenocarcinoma and Cervical Cancer, run by Women's Hospital School Of Medicine Zhejiang University.
Trial summary
Background: Gastric-type endocervical adenocarcinoma (G-EAC) is a new classification of cervical mucinous carcinoma. G-EAC is a unique human papillomavirus unrelated adenocarcinoma that can be distinguished from typical endocervical adenocarcinoma (UEA). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Gastric-type Endocervical Adenocarcinoma, Cervical Cancer
- What is being tested?
- paclitaxel and platinum and platinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed Gastric-type endocervical adenocarcinoma;
- Based on standard examination procedures, it is determined that one of the following risk factors is combined: positive margin, positive paracervical involvement, adnexal involvement, positive lymph nodes, tumor diameter ≥ 4cm, infiltration of the outer 1/3 of the cervical stroma, and vascular tumor thrombus. The specific inclusion can be discussed by two senior clinical doctors;
- Medical history inquiry and gynecological examination must be performed within 14 days before enrollment to confirm the size of the tumor and International Federation of Gynecology and Obstetrics (FIGO) stage;
- Chest Computed Tomography (CT) plain scan, abdominal enhanced CT scan, or Positron Emission Tomography (PET)/CT examination within 30 days before enrollment;
- Pelvic CT, Magnetic Resonance Imaging (MRI) or PET/CT examination within 30 days before enrollment;
- General condition score 0-1 points;
Show all 15Show fewer
- Age 18-65 years old;
- Laboratory examinations must be performed within 14 days before enrollment, and bone marrow, liver function, and kidney function tests are performed:
- White blood cell (WBC) ≥ 3.5 x 10E9/L (normal range)
- Neutrophils ≥ 1.5 x 10E9/L;
- Platelets ≥ 100 x 10E9/L;
- Hemoglobin ≥ 100 g/L (transfusion or other methods are acceptable)
- Liver function is within the normal range: alanine aminotransferase (ALT), aspartate aminotransferase (AST) < 1.5 times the upper limit of normal, alkaline phosphatase (ALP) < 2.5 times the upper limit of normal, bilirubin < upper limit of normal.
- Renal function is within the normal range: creatinine clearance rate (CCr) > 60 ml/min.
- Calculation formula: CCr=(140-age)×weight (kg)/[72×Scr (mg/dl)] or CCr=[(140-age)×weight (kg)]/[0.818×Scr (umol/L)] g) International prothrombin ratio (INR) ≤ 1.5 9. Women of childbearing age must agree to take effective contraceptive measures during the entire treatment study; 10. Patients must sign an informed consent form before enrollment;
Who cannot join
- Pathological types of non-gastric adenocarcinomas such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, small cell carcinoma, neuroendocrine carcinoma, and sarcoma of cervical cancer;
- Stage IVB;
- Previous invasive malignant tumors: excluding non-malignant melanoma skin cancer;
- Systemic chemotherapy in the past 3 years;
- Previous history of pelvic or abdominal radiotherapy, which may cause overlap of irradiation field for this radiotherapy;
- Distant metastatic lesions in other organs;
- The following serious active concurrent diseases:
- 1) Unstable angina and/or congestive heart failure requiring hospitalization in the past 6 months 2) Transmural myocardial infarction in the past 6 months 3) Acute bacterial or fungal infection requiring intravenous antibiotic treatment at the time of registration 4) Exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization or hindering the study 5) Jaundice or coagulation disorder caused by poor liver function 6) Acquired immunodeficiency disease (Patients diagnosed with Acquired Immune Deficiency Syndrome (AIDS), or patients suspected of having AIDS who refuse HIV testing); 7) Other immunocompromised states (e.g. organ transplantation, long-term use of glucocorticoids); 8. Pregnant women, breastfeeding women.
About this study
Official title: A Multicenter Randomized Study Comparing Paclitaxel and Platinum-based Concurrent Chemoradiotherapy With Short-term Adjuvant Chemotherapy Versus Platinum-based Monotherapy Concurrent Chemoradiotherapy in Patients With Postoperative Cervical Gastric-type Adenocarcinoma With High-risk Factors for Recurrence.
Background: Gastric-type endocervical adenocarcinoma (G-EAC) is a new classification of cervical mucinous carcinoma. G-EAC is a unique human papillomavirus unrelated adenocarcinoma that can be distinguished from typical endocervical adenocarcinoma (UEA). In China, adjuvant therapy for cervical cancer after surgery includes not only radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), but also chemotherapy in many cases. However, no previous prospective study has analyzed the adjuvant therapy of G-EAC. This study is the first randomized phase III trial, which aims to recommend better adjuvant treatment options for G-EAC patients at high risk of recurrence in China, in order to better optimize and personalize patient care and improve recurrence-free survival and overall survival.
Methods: This trial is a prospective, multicenter study led by the Department of Radiotherapy, Affiliated Hospital of Obstetrics and Gynecology, Zhejiang University. Recruitment will begin in February 2025, and it is expected that 238 patients with postoperative cervical gastric adenocarcinoma with high risk of recurrence will be recruited from 16 clinical centers in China. Patients will be randomly assigned to the experimental group or the control group in a 1:1 ratio. The experimental group will receive paclitaxel combined with platinum-based concurrent chemoradiotherapy and short-term adjuvant chemotherapy, and the control group will receive the current standard treatment regimen, i.e., platinum-based concurrent chemoradiotherapy, without adjuvant chemotherapy. The primary endpoint of the study is the 2-year progression-free survival, and the secondary endpoints are disease treatment failure pattern, overall survival rate, acute/chronic toxicity incidence, and quality of life assessment.
- Being tested
- paclitaxel and platinum, platinum
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel and platinumDrug
After the start of External Beam Radiation Therapy (EBRT), paclitaxel (150-175 mg/m2) or paclitaxel (albumin-bound) 222-260 mg/m2 + cisplatin (60-75 mg/m2) or carboplatin [Area Under Curve (AUC) = 4-5], Q3W (every 3 weeks is a dosing cycle), administered on the first day of each cycle, for a total of 4 cycles. Adjuvant chemotherapy started 4 weeks after the end of external irradiation therapy, and chemotherapy-related adverse reactions dropped to grade 2 or below before chemotherapy began. If not met, it can be postponed for 2 weeks.
platinumDrug
During EBRT, cisplatin (40 mg/m2) or carboplatin (AUC = 2) was used for concurrent chemotherapy once a week for a total of 5 times. On the day of cisplatin infusion, radiotherapy should be performed after cisplatin or carboplatin.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Not described Receives: Drug: paclitaxel and platinum |
| Control arm | Active comparator | Not described Receives: Drug: platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year progression-free survival (PFS)
Measured: 2 year
Secondary outcomes (4)
Disease failure pattern
The pattern of disease failure will be assessed by the site and number of recurrences or distant metastases.
Measured: 2 year
Overall survival rate
Measured: 2 year
Incidence of acute/chronic toxicity
Measured: 2 year
Quality of life assessment
Quality of life assessment (time node: 2 years). The patients'quality of life will be assessed using the Quality of Life Questionnaire-Core 30 (QLQ-C30) scale.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric-type Endocervical AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiu Tang, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870565
- Sponsor's protocol ID
- IRB-20250032-R
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qu W, Wang H, Jin N, Tang Q. Comparing paclitaxel and platinum-based concurrent chemoradiotherapy with short-term adjuvant chemotherapy versus platinum-based monotherapy concurrent chemoradiotherapy in patients with postoperative gastric-type endocervical adenocarcinoma with high-risk factors for recurrence: a multicenter randomized phase III trial. J Gynecol Oncol. 2026 Jul;37(4):e79. doi: 10.3802/jgo.2026.37.e79. Epub 2026 Feb 25.
PubMed 41834413
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Study Comparing Paclitaxel and Platinum-based Concurrent Chemoradiotherapy With Short-term Adjuvant Chemotherapy Versus Platinum-based Monotherapy Concurrent Chemoradiotherapy in Patients With Postoperative Cervical Gastric-type Adenocarcinoma With High-risk Factors for Recurrence.
- ClinicalTrials.gov ID
- NCT06870565
- Acronym / sponsor ID
- IRB-20250032-R
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Gastric-type endocervical adenocarcinoma (G-EAC) is a new classification of cervical mucinous carcinoma. G-EAC is a unique human papillomavirus unrelated adenocarcinoma that can be distinguished from typical endocervical adenocarcinoma (UEA). In China, adjuvant therapy for cervical cancer after surgery includes not only radiotherapy (RT) or concurrent chemoradiotherapy (CCRT), but also chemotherapy in many cases. However, no previous prospective study has analyzed the adjuvant therapy of G-EAC. This study is the first randomized phase III trial, which aims to recommend better adjuvant treatment options for G-EAC patients at high risk of recurrence in China, in order to better optimize and personalize patient care and improve recurrence-free survival and overall survival.
Methods: This trial is a prospective, multicenter study led by the Department of Radiotherapy, Affiliated Hospital of Obstetrics and Gynecology, Zhejiang University. Recruitment will begin in February 2025, and it is expected that 238 patients with postoperative cervical gastric adenocarcinoma with high risk of recurrence will be recruited from 16 clinical centers in China. Patients will be randomly assigned to the experimental group or the control group in a 1:1 ratio. The experimental group will receive paclitaxel combined with platinum-based concurrent chemoradiotherapy and short-term adjuvant chemotherapy, and the control group will receive the current standard treatment regimen, i.e., platinum-based concurrent chemoradiotherapy, without adjuvant chemotherapy. The primary endpoint of the study is the 2-year progression-free survival, and the secondary endpoints are disease treatment failure pattern, overall survival rate, acute/chronic toxicity incidence, and quality of life assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: paclitaxel and platinum |
| Control arm | Active comparator | Drug: platinum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically confirmed Gastric-type endocervical adenocarcinoma;
- Based on standard examination procedures, it is determined that one of the following risk factors is combined: positive margin, positive paracervical involvement, adnexal involvement, positive lymph nodes, tumor diameter ≥ 4cm, infiltration of the outer 1/3 of the cervical stroma, and vascular tumor thrombus. The specific inclusion can be discussed by two senior clinical doctors;
- Medical history inquiry and gynecological examination must be performed within 14 days before enrollment to confirm the size of the tumor and International Federation of Gynecology and Obstetrics (FIGO) stage;
- Chest Computed Tomography (CT) plain scan, abdominal enhanced CT scan, or Positron Emission Tomography (PET)/CT examination within 30 days before enrollment;
- Pelvic CT, Magnetic Resonance Imaging (MRI) or PET/CT examination within 30 days before enrollment;
Key exclusion criteria (8 listed)
- Pathological types of non-gastric adenocarcinomas such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, small cell carcinoma, neuroendocrine carcinoma, and sarcoma of cervical cancer;
- Stage IVB;
- Previous invasive malignant tumors: excluding non-malignant melanoma skin cancer;
- Systemic chemotherapy in the past 3 years;
- Previous history of pelvic or abdominal radiotherapy, which may cause overlap of irradiation field for this radiotherapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel and platinumAfter the start of External Beam Radiation Therapy (EBRT), paclitaxel (150-175 mg/m2) or paclitaxel (albumin-bound) 222-260 mg/m2 + cisplatin (60-75 mg/m2) or carboplatin [Area Under Curve (AUC) = 4-5], Q3W (every 3 weeks is a dosing cycle), administered on the first day of each cycle, for a total of 4 cycles. Adjuvant chemotherapy started 4 weeks after the end of external irradiation therapy, and chemotherapy-related adverse reactions dropped to grade 2 or below before chemotherapy began. If not met, it can be postponed for 2 weeks. | Drug | Experimental arm |
| platinumDuring EBRT, cisplatin (40 mg/m2) or carboplatin (AUC = 2) was used for concurrent chemotherapy once a week for a total of 5 times. On the day of cisplatin infusion, radiotherapy should be performed after cisplatin or carboplatin. | Drug | Control arm |
Primary outcome
2-year progression-free survival (PFS)
Time frame: 2 year
4 secondary outcomes
Disease failure pattern
Time frame: 2 year
Overall survival rate
Time frame: 2 year
Incidence of acute/chronic toxicity
Time frame: 2 year
Quality of life assessment
Time frame: 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41834413Qu W, Wang H, Jin N, Tang Q. Comparing paclitaxel and platinum-based concurrent chemoradiotherapy with short-term adjuvant chemotherapy versus platinum-based monotherapy concurrent chemoradiotherapy in patients with postoperative gastric-type endocervical adenocarcinoma with high-risk factors for recurrence: a multicenter randomized phase III trial. J Gynecol Oncol. 2026 Jul;37(4):e79. doi: 10.3802/jgo.2026.37.e79. Epub 2026 Feb 25.
- Individual participant dataSharing planned: No
Related trials for Gastric-type Endocervical Adenocarcinoma
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
RecruitingPhase 2
IN10018 With Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma: Phase 2 Trial
Cervical Adenocarcinoma, Gastric-type Endocervical Adenocarcinoma
RecruitingPhase 2
A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
Gastric Type Adenocarcinoma (GAS) With STK11 Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paclitaxel and platinum and platinum in people with Gastric-type Endocervical Adenocarcinoma and Cervical Cancer, run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (PFS) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06870565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.