Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients (NCT03308591) | Clinical Trial Compass
CompletedPhase 3
Clinical Efficacy of the Neoadjuvant Chemotherapy for IB2 and IIA2 Stage Cervical Cancer Patients
China774 participantsStarted 2016-01-11
Plain-language summary
In recent years, the patients with IB2 and IIA2 stage cervical cancer are still treated with radiotherapy and chemotherapy based treatment, but the radiotherapy will severely damage the function of ovary, cause endocrine dyscrasia and the sexual function of vagina. So we want to study whether neoadjuvant chemotherapy without radiotherapy will achieve the same outcome compared with traditional therapy including radiotherapy. So we randomly divide IB2 and IIA2 stage cervical cancer patients into two groups. The neoadjuvant chemotherapy group will receive two courses of chemotherapy basically composed of platinum, and then undergo surgery, after that, doctors will add more courses of chemotherapy according to the situations of the patients, including whether the patients have the adverse prognostic factors. The control group will undergo surgery directly, and then receive chemotherapy and radiotherapy at the same time. Then we will compare the outcomes of these two groups, and analyze the therapeutic effect, the impact on survival rate and the effect on improving the living quality of patient from two groups. All the outcomes will be fed back to clinical doctors and instruct them to choose better treatment for patients.
Who can participate
Age range
65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* clinical diagnosis IB2 or IIA2 stage cervical cancer;
* age less than or equal to 65 years old;
* laboratory examination results: WBC ≥ 4\*10\^9/L, NEU ≥ 20\*10\^9/L, PLT ≥ 80\*10\^9/L, serum bilirubin ≤ 2 multiples of the upper normal limit, aminopherase ≤ 2 multiples of the upper normal limit. BUN ≤ normal limit, CR ≤ normal limit;
* KARNOFSKY score ≥ 60;
* No prior treatment;
* pathological diagnosis before surgery is invasive squamous cell carcinoma of cervix;
* well-compliance and willing to keep in touch;
* willing to participate in this study, and sign the informed consent;
Exclusion Criteria:
* participate in other drug clinical trials at the same time;
* respiratory depression, airway obstruction and hypoxia;
* heart diseases (cardiac function at grade II, III or above);
* hematological diseases;
* obvious dysfunction of liver and kidney (above 3 multiples of the upper normal limit);
* a history of brain dysfunction;
* unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
* drug abuse or a history of drug abuse;
* unable or unwilling to sign informed consents;
* unable or unwilling to follow the protocols;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
disease-free survival (DFS) of the neoadjuvant chemotherapy Group
Timeframe: Up to 3-year
Trial details
NCT IDNCT03308591
SponsorHuazhong University of Science and Technology