Uterine Cervical NeoplasmsCC-01NCT01755897
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
A study testing radical hysterectomy + pelvic lymph node dissection, Paclitaxel and Cisplatin in people with Uterine Cervical Neoplasms and Cervical Cancer, run by Huazhong University of Science and Technology at 3 sites in China.
Trial summary
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors. Read more about this study
- Who is it for?
- Ages Up to 65 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer
- What is being tested?
- radical hysterectomy + pelvic lymph node dissection, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 3 sitesChina
- Study dates
- Nov 2012to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- FIGO stage: ⅠB～ⅡA, cervical cancer;
- Age≤60 years; female, Chinese women;
- Initial treatment is radical hysterectomy + pelvic lymph node dissection;
- Pathological diagnosis: cervical squamous cell invasive carcinoma;
- Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter> 4cm;
- Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
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- Performance status: Karnofsky score≥60;
- No prior treatment;
- Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide resection; pathologically diagnosed with cervical squamous cell carcinoma;
- Provide written informed consent.
Who cannot join
- With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
- History of organ transplantation, immune diseases;
- History of serious mental illness, a history of brain dysfunction;
- Drug abuse or a history of drug abuse;
- Suffering from other malignancies;
- Concurrently participating in other clinical trials
- Unable or unwilling to sign informed consents;
- Unable or unwilling to abide by protocol.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Women's Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310006
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
- Being tested
- radical hysterectomy + pelvic lymph node dissection, Paclitaxel, Cisplatin, Pelvic RT
- 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.
radical hysterectomy + pelvic lymph node dissectionProcedure or surgery
PaclitaxelDrug
135-175 mg/m(2) intravenously (IV) on day 1
CisplatinDrug
75 mg/m(2) IV on day 2 and 3
CisplatinDrug
35 mg/m(2) IV once a week
Pelvic RTRadiation
IMRT
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Chemotherapy (Arm A) | Experimental | Paclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary. Receives: Procedure: radical hysterectomy + pelvic lymph node dissection; Drug: Paclitaxel; Drug: Cisplatin |
| Concurrent radiochemotherapy, CCRT (Arm B) | Active comparator | Pelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks. Receives: Procedure: radical hysterectomy + pelvic lymph node dissection; Drug: Cisplatin; Radiation: Pelvic RT |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS)
DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
Measured: up to 3-year
Secondary outcomes (3)
3-year overall survivals (OS)
Measured: 3-year
Quality of Life in two arms
Measured: 3 years
chemotherapy- and radiotherapy- related adverse effects respectively in two arms
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2017
- Study completionDec 2020
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 Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Shandong University
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, MD, PhD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755897
- Sponsor's protocol ID
- CSEM GOG-002
- Other IDs
- 2012-GYN/CC-01
- Acronym
- CC-01
- Status last verified
- May 2023
- First submitted
- 19 Dec 2012
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weng D, Xiong H, Zhu C, Wan X, Chen Y, Wang X, Zhang Y, Jiang J, Zhang X, Gao Q, Chen G, Xing H, Wang C, Li K, Chen Y, Mao Y, Hu D, Pan Z, Chen Q, Cui B, Song K, Yi C, Peng G, Han X, An R, Fan L, Wang W, Xiong T, Chen Y, Tang Z, Li L, Yang X, Cheng X, Lu W, Wang H, Kong B, Xie X, Ma D. Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial. Front Med. 2023 Feb;17(1):93-104. doi: 10.1007/s11684-021-0892-z. Epub 2022 Nov 23.
PubMed 36422763
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
- ClinicalTrials.gov ID
- NCT01755897
- Acronym / sponsor ID
- CC-01 / CSEM GOG-002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Zhejiang University, Shandong University
- Study start
- Nov 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 24 Dec 2012 (estimated)
- 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.
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical cancer patients with risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Chemotherapy (Arm A) | Experimental | Procedure: radical hysterectomy + pelvic lymph node dissection, Drug: Paclitaxel, Drug: CisplatinPaclitaxel (T): 135-175 mg/m(2) intravenously (IV) on day 1, administrated intravenously over 3 hours; followed by cisplatin 75-85 mg/m(2) IV on day 2 and 3. Patients received at least 3 cycles at 4-week intervals beginning 2-3 weeks after surgery. 3-6 cycles as necessary. |
| Concurrent radiochemotherapy, CCRT (Arm B) | Active comparator | Procedure: radical hysterectomy + pelvic lymph node dissection, Drug: Cisplatin, Radiation: Pelvic RTPelvic RT is delivered using IMRT technique, 45～50.4 Gy/4～7 weeks, brachytherapy will been given as necessary. Cisplatin 35 mg/m(2) IV once a week. Total treatment time is 6-7 weeks. |
Who may qualify
- Ages
- Up to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- FIGO stage: ⅠB～ⅡA, cervical cancer;
- Age≤60 years; female, Chinese women;
- Initial treatment is radical hysterectomy + pelvic lymph node dissection;
- Pathological diagnosis: cervical squamous cell invasive carcinoma;
- Pathologic examination and meet the following one of the indications of adjuvant therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic vascular space involvement, ⑥ tumor diameter> 4cm;
Key exclusion criteria (8 listed)
- With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy
- History of organ transplantation, immune diseases;
- History of serious mental illness, a history of brain dysfunction;
- Drug abuse or a history of drug abuse;
- Suffering from other malignancies;
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 |
|---|---|---|
| radical hysterectomy + pelvic lymph node dissection | Procedure or surgery | Adjuvant Chemotherapy (Arm A), Concurrent radiochemotherapy, CCRT (Arm B) |
| Paclitaxel135-175 mg/m(2) intravenously (IV) on day 1 | Drug | Adjuvant Chemotherapy (Arm A) |
| Cisplatin75 mg/m(2) IV on day 2 and 3 | Drug | Adjuvant Chemotherapy (Arm A) |
| Cisplatin35 mg/m(2) IV once a week | Drug | Concurrent radiochemotherapy, CCRT (Arm B) |
| Pelvic RTIMRT | Radiation | Concurrent radiochemotherapy, CCRT (Arm B) |
Primary outcome
disease-free survival (DFS)
Time frame: up to 3-year
DFS was definite as the time from randomization to disease recurrence (including death from recurrence if it was the first manifestation of recurrence), death without recurrence.
3 secondary outcomes
3-year overall survivals (OS)
Time frame: 3-year
Quality of Life in two arms
Time frame: 3 years
chemotherapy- and radiotherapy- related adverse effects respectively in two arms
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 36422763Weng D, Xiong H, Zhu C, Wan X, Chen Y, Wang X, Zhang Y, Jiang J, Zhang X, Gao Q, Chen G, Xing H, Wang C, Li K, Chen Y, Mao Y, Hu D, Pan Z, Chen Q, Cui B, Song K, Yi C, Peng G, Han X, An R, Fan L, Wang W, Xiong T, Chen Y, Tang Z, Li L, Yang X, Cheng X, Lu W, Wang H, Kong B, Xie X, Ma D. Adjuvant chemotherapy versus adjuvant concurrent chemoradiotherapy after radical surgery for early-stage cervical cancer: a randomized, non-inferiority, multicenter trial. Front Med. 2023 Feb;17(1):93-104. doi: 10.1007/s11684-021-0892-z. Epub 2022 Nov 23.
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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. This study is not recruiting at the moment.
Ding Ma, MD, PhD study chair
Huazhong University of Science and Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radical hysterectomy + pelvic lymph node dissection, Paclitaxel and Cisplatin in people with Uterine Cervical Neoplasms and Cervical Cancer, run by Huazhong University of Science and Technology at 3 sites in China.
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 10 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: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease-free survival (DFS) (time frame: up to 3-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 NCT01755897, 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 9 May 2023.