Evaluating chemotherapy effectiveness after treatment for advanced cervical cancer

Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer

This study is testing if adding chemotherapy after initial treatment helps women with advanced cervical cancer who still have some cancer left feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT04409860 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the efficacy of adjuvant chemotherapy in patients with locally advanced cervical cancer who have residual lesions following concurrent chemoradiation therapy (CCRT). Patients with stage IIb to IVa cervical cancer and specific histopathological types will be randomized into two groups: one receiving observation and the other receiving adjuvant chemotherapy with paclitaxel and cisplatin. The study will compare response rates and survival outcomes between the two groups to determine the potential benefits of adding chemotherapy after CCRT.

Who should consider this trial

Good fit: Ideal candidates are women with stage IIb to IVa cervical cancer who have undergone complete CCRT and have residual lesions as confirmed by MRI.

Not a fit: Patients with severe infections, liver cirrhosis, or those with a history of immune deficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates for patients with advanced cervical cancer who have residual disease after initial treatment.

How similar studies have performed: Previous studies have shown promising results with adjuvant chemotherapy in similar patient populations, suggesting potential for success in this approach.

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

Where this trial is running

Chongqing, Chongqing Municipality

• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou, M.D.

Conditions Cervical Cancer; Locally adcanced; CCRT; Adjuvant chemotherapy