The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer (CQGOG0102)

Chongqing University Cancer Hospital

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Drug: Paclitaxel, Cisplatin; Radiation: CCRT

Study type: Interventional

Funder types: Other

Identifiers

NCT04409860

CQGOG0102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

control group

Active Comparator group

Description:

In this group, observation is given after CCRT.

Treatment:

Radiation: CCRT

trial group

Experimental group

Description:

In this group, adjuvant chemotherapy is given after CCRT.

Treatment:

Radiation: CCRT

Drug: Paclitaxel, Cisplatin