Clinical trial NCT04409860: The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Official title: Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Locally adcanced
CCRT
Adjuvant chemotherapy
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PFS
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 5 years
measure: ORR
timeFrame: 3 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Dongling Zou, M.D.
role: PRINCIPAL_INVESTIGATOR
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