The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия CCRT
  Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
• Препарат Paclitaxel, Cisplatin
  The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.

Первичные конечные точки

• PFS [Срок оценки: 2 years]

Вторичные конечные точки (2)

• OS [Срок оценки: 5 years]
• ORR [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
• Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
• MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
• ECOG<2
• Expected survival is longer than six months
• Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
• ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
• 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

Критерии исключения

• Activity or uncontrol severe infection
• Liver cirrhosis, Decompensated liver disease
• History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
• Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
• Have suffered or combined with other malignant tumor
• Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
• A history targeted therapy or pelvic artery embolization
• Artery-enous thrombosis within 6 months
• Patients with autoimmune diseases
• Complications, need to be treatment with drugs which may lead to liver or kidney injury
• Patients with disease progression after chemoradiation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chongqing Cancer Hospital — Чунцин

Публикации

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• Verma J, Monk BJ, Wolfson AH. New Strategies for Multimodality Therapy in Treating Locally Advanced Cervix Cancer. Semin Radiat Oncol. 2016 Oct;26(4):344-8. doi: 10.1016/j.semradonc.2016.05.003. Epub 2016 May 26. PMID 27619255
• Rose PG. Chemoradiotherapy for cervical cancer. Eur J Cancer. 2002 Jan;38(2):270-8. doi: 10.1016/s0959-8049(01)00352-5. PMID 11803143
• Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration. Reducing uncertainties about the effects of chemoradiotherapy for cervical cancer: a systematic review and meta-analysis of individual patient data from 18 randomized trials. J Clin Oncol. 2008 Dec 10;26(35):5802-12. doi: 10.1200/JCO.2008.16.4368. Epub 2008 Nov 10. PMID 19001332
• Chereau E, DE LA Hosseraye C, Ballester M, Monnier L, Rouzier R, Touboul E, Darai E. The role of completion surgery after concurrent radiochemotherapy in locally advanced stages IB2-IIB cervical cancer. Anticancer Res. 2013 Apr;33(4):1661-6. PMID 23564812
• Carcopino X, Houvenaeghel G, Buttarelli M, Esterni B, Tallet A, Goncalves A, Jacquemier J. Equivalent survival in patients with advanced stage IB-II and III-IVA cervical cancer treated by adjuvant surgery following chemoradiotherapy. Eur J Surg Oncol. 2008 May;34(5):569-75. doi: 10.1016/j.ejso.2007.04.006. Epub 2007 May 25. PMID 17531428
• Hequet D, Marchand E, Place V, Fourchotte V, De La Rochefordiere A, Dridi S, Coutant C, Lecuru F, Bats AS, Koskas M, Bretel JJ, Bricou A, Delpech Y, Barranger E. Evaluation and impact of residual disease in locally advanced cervical cancer after concurrent chemoradiation therapy: results of a multicenter study. Eur J Surg Oncol. 2013 Dec;39(12):1428-34. doi: 10.1016/j.ejso.2013.10.006. Epub 2013 O PMID 24183796
• Ferrandina G, Margariti PA, Smaniotto D, Petrillo M, Salerno MG, Fagotti A, Macchia G, Morganti AG, Cellini N, Scambia G. Long-term analysis of clinical outcome and complications in locally advanced cervical cancer patients administered concomitant chemoradiation followed by radical surgery. Gynecol Oncol. 2010 Dec;119(3):404-10. doi: 10.1016/j.ygyno.2010.08.004. PMID 20817228

Идентификаторы

NCT: NCT04409860 · CQGOG0102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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