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A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients (CC-01)

Primary Purpose

Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
radical hysterectomy + pelvic lymph node dissection
Paclitaxel
Cisplatin
Cisplatin
Pelvic RT
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Qilu Hospital, Shandong University
  • Women's Hospital, School of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjuvant Chemotherapy (Arm A)

Concurrent radiochemotherapy, CCRT (Arm B)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

3-year overall survivals (OS)
Quality of Life in two arms
chemotherapy- and radiotherapy- related adverse effects respectively in two arms

Full Information

First Posted
December 19, 2012
Last Updated
May 7, 2023
Sponsor
Huazhong University of Science and Technology
Collaborators
Zhejiang University, Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT01755897
Brief Title
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Acronym
CC-01
Official Title
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Zhejiang University, Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Cervical Cancer, Uterine Cervical Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
337 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Chemotherapy (Arm A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Concurrent radiochemotherapy, CCRT (Arm B)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
radical hysterectomy + pelvic lymph node dissection
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
135-175 mg/m(2) intravenously (IV) on day 1
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m(2) IV on day 2 and 3
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
35 mg/m(2) IV once a week
Intervention Type
Radiation
Intervention Name(s)
Pelvic RT
Intervention Description
IMRT
Primary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
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.
Time Frame
up to 3-year
Secondary Outcome Measure Information:
Title
3-year overall survivals (OS)
Time Frame
3-year
Title
Quality of Life in two arms
Time Frame
3 years
Title
chemotherapy- and radiotherapy- related adverse effects respectively in two arms
Time Frame
3 years

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ding Ma, MD, PhD
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Women's Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
36422763
Citation
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.
Results Reference
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A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients

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