The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Radiation: CCRT; Drug: Paclitaxel, Cisplatin

• Registration Number: NCT04409860
• Lead Sponsor: Chongqing University Cancer Hospital

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.

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.

2. Patients:

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).

3. 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 Timeline

• Study First Submitted: 2020-05-23
• Study Start: 2020-05-26
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-08
• Last Update Posted: 2023-04-11
• Primary Completion: 2024-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	CCRT	In this group, observation is given after CCRT.
trial group	CCRT	In this group, adjuvant chemotherapy is given after CCRT.
trial group	Paclitaxel, Cisplatin	In this group, adjuvant chemotherapy is given after CCRT.

Primary Outcome Measures

Name	Time	Method
PFS	2 years	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
ORR	3 months	To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer
OS	5 years	5 years overall survival

Trial Locations

Locations (1)

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China