NCT04588090

Brief Summary

the main purpose for this experiments are as follows: 1. Patients with stage ⅡB-ⅢB cervical squamous cell carcinoma who received full dose radiotherapy will be randomly assigned to the combined TP regimen weekly treatment group and 3-week treatment group for the short-term efficacy and safety observation; 2. All enrolled patients will be tested for HPV subtype infection; the relationship between the sensitivity and curative effect of concurrent radiotherapy and chemotherapy will be analyzed, and at the end of the test, HPV subtypes will be tested again and changes will be analyzed to provide more clinical evidence for the reasonable comprehensive treatment and precision medical treatment of advanced cervical squamous cell carcinoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

5 years

First QC Date

September 30, 2020

Last Update Submit

October 8, 2020

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

  • disease control rate (DCR)

    Including the percentage of patients with complete remission, partial remission or with stable disease state and maintained for more than 4 weeks among the patients with evaluable efficacy.

    1 month and 3 months

  • Objective response rate (ORR)

    Including the percentage of patients with complete remission or partial remission and maintained for more than 4 weeks among the patients with evaluable efficacy.

    1 month and 3 months

Secondary Outcomes (2)

  • progression-free survival (PFS)

    2 years

  • overall survival (OS)

    3 years

Study Arms (2)

Experimental group

EXPERIMENTAL

The concurrent 3 weeks treatment group（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing 3 weeks chemotherapy）

Procedure: The concurrent 3 weeks TP regimenRadiation: External radiation plus intraluminal after-loading irradiation

Standard chemoradiation group

PLACEBO COMPARATOR

Standard chemoradiation（external radiation plus intraluminal after-loading irradiation+concurrent platinum-containing weekly chemotherapy）

Procedure: The concurrent weekly TP regimenRadiation: External radiation plus intraluminal after-loading irradiation

Interventions

The concurrent 3 weeks TP regimenPROCEDURE

paclitaxel + cisplatin regimen (TP-TAX: 150mg/m\^2, DDP: 70mg/m\^2 (35mg/m\^2, d1, d2), 1 time/3 weeks) chemotherapy for 2 cycles.

Experimental group
The concurrent weekly TP regimenPROCEDURE

paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m\^2, DDP: 25mg/m\^2) 6 cycles of chemotherapy

Standard chemoradiation group
External radiation plus intraluminal after-loading irradiationRADIATION

External radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation.

Experimental groupStandard chemoradiation group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient participated in this study voluntarily and all volunteers will sign the informed consent.
  • New cervical squamous cell carcinoma cases between 18 and 70 years old;
  • Clinical stages: stage ⅡB-stage ⅢB;
  • PS score is less than 2 points;
  • Expected survival is over 3 months;
  • Blood routine: Hb≥70g/L, WBC≥3.5×10\^9/L, ANC≥1.5×10\^9/L, PLT≥80×10\^9/L
  • Serum ALT and AST≤2×ULN; serum creatinine≤1.5×ULN;
  • Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the trial;
  • Patients who can comply with the trial protocol (judged by the investigator).

You may not qualify if:

  • Active or uncontrolled serious infection;
  • Liver cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis require antiviral treatments;
  • A history of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency diseases;
  • Chronic renal insufficiency and renal failure;
  • Pregnant woman;
  • Myocardial infarction, severe arrhythmia and congestive heart failure ≥2 (New York Heart Association (NYHA) classification);
  • Patients receiving targeted therapy and pelvic artery embolism;
  • Those who have had arterial/venous thrombosis within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
  • Those who have received radiotherapy for malignant pelvic tumors in the past;
  • Patients with autoimmune system diseases such as systemic lupus erythematosus;
  • Patients with comorbidities who need to take drugs with severe liver and kidney damage during treatment, such as tuberculosis;
  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent;
  • Those with concomitant diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

TP protocol

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

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
Director

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 19, 2020

Study Start

January 1, 2016

Primary Completion

January 1, 2021

Study Completion

May 1, 2021

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)