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CQGOG0102: The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

Sponsor
Chongqing University Cancer Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04409860
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
94.2
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Condition or Disease Intervention/Treatment Phase
  • Radiation: CCRT
  • Drug: Paclitaxel, Cisplatin
 N/A

Detailed Description

  1. Objective:

To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT.

  1. Patients:

  2. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma

  3. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin）

  4. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).

  5. Methods:

The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Actual Study Start Date :
May 26, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

In this group, observation is given after CCRT.

Radiation: CCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
Other Names:
  • control group: CCRT + observation

    		•
    Experimental: trial group

    In this group, adjuvant chemotherapy is given after CCRT.

    Radiation: CCRT
    Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
    Other Names:
  • control group: CCRT + observation

    • Drug: Paclitaxel, Cisplatin
    The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
    Other Names:
  • trial group: CCRT + adjuvant chemotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PFS [2 years]

      Progression-free survival

    Secondary Outcome Measures

    1. OS [5 years]

      5 years overall survival

    2. ORR [3 months]

      To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma

    2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))

    3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).

    4. ECOG<2

    5. Expected survival is longer than six months

    6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L

    7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN

    8. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial

    Exclusion Criteria:

    1. Activity or uncontrol severe infection

    2. Liver cirrhosis, Decompensated liver disease

    3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease

    4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure

    5. Have suffered or combined with other malignant tumor

    6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure

    7. A history targeted therapy or pelvic artery embolization

    8. Artery-enous thrombosis within 6 months

    9. Patients with autoimmune diseases

    10. Complications, need to be treatment with drugs which may lead to liver or kidney injury

    11. Patients with disease progression after chemoradiation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chongqing Cancer Hospital Chongqing Chongqing China 400030

    Sponsors and Collaborators

    • Chongqing University Cancer Hospital

    Investigators

    • Principal Investigator: Dongling Zou, M.D., Chongqing University Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dongling Zou, Associated Director, Chongqing University Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT04409860
    Other Study ID Numbers:
    • CQGOG0102
    First Posted:
    Jun 1, 2020
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dongling Zou, Associated Director, Chongqing University Cancer Hospital
    Locally adcanced
    CCRT
    Adjuvant chemotherapy
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Paclitaxel
    Cisplatin

    Study Results

    No Results Posted as of Apr 25, 2022