CTRI/2021/03/031977招募中3 期
A Phase III Randomized Controlled Trial of Hyperthermic or Normothermic Intraperitoneal Chemotherapy versus No Intraperitoneal Chemotherapy during Interval Debulking Surgery in Patients with Advanced Epithelial Ovarian Cancer â?? HIPEC or NIPEC versus None: (ROHINI-N)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion criteria at time of Registration:
- •1)Patients with cytopathologically and/or histopathologically proven epithelial ovarian cancer or fallopian tube or primary peritoneal cancer.
- •2)Patients who are planned to be treated with neoadjuvant chemotherapy followed by interval debulking surgery followed by adjuvant chemotherapy.
- •3)At least 18 years of age at the time of Registration in the study.
- •4)Patients with ECOG performance status <=3 at the time of Registration in the study.
- •5)Patients with radiological evidence of stage III or IVA epithelial ovarian cancer or those with less than radiological stage III but with massive ascites requiring neoadjuvant chemotherapy.
- •6)Adequate hematological (defined as a white blood cell count of >=3 Ã? 10â?¹ cells per L with an absolute neutrophil count >=1·5 Ã? 10â?¹ cells per L, platelet count >=100 Ã? 10â?¹platelets per L, and haemoglobin >=8 g/dL [may have been transfused]), liver (defined as a total bilirubin concentration of <=1·5 Ã? the upper limit of normal [ULN] range and aspartate aminotransferase and alanineaminotransferase concentrations of <=2.5 x Ã? ULN; however if patient has liver metastases,aspartate aminotransferase and alanine aminotransferase concentrations of <=5 Ã? ULN are acceptable) and renal (defined as an estimated creatinine clearance >45 ml/min according to the Cockcroft-Gault formula) functions at the time of Registration.
- •7)Written informed consent prior to study inclusion.
- •Inclusion Criteria after NACT up to the time of intra-operative randomization:
- •1)Patients who have received 3 cycles of neoadjuvant chemotherapy. Occasional patients who have received 4 cycles of NACT can also be included in the study with appropriate justification for the 4th NACT cycle.
- •2)Patients should have received NACT with paclitaxel (starting dose 175/m2) plus carboplatin (AUC 5-6) every 3 weeks. Dose reductions of both drugs during neoadjuvant chemotherapy because of toxicity will be allowed as per standard practice at the institution and as indicated in Table 1. Drug modification in the form of change of agent (substitution of paclitaxel with another non-platinum agent and/ or substitution of carboplaitin with cisplatin) or omission of a drug because of toxicity will be allowed at the treating physicianâ??s discretion as clinically indicated and as per standard practice at the institution.
- •3)Patients who have attained complete or partial response (CR or PR) after 3 (or 4) cycles of NACT.
- •4)Patient is considered fit for major surgery, either ASA category 1 or category 2
- •5)ECOG 0-2 before planned interval debulking surgery
- •6)Adequate hematological (defined as a white blood cell count of >=3 Ã? 10â?¹ cells per L with an absolute neutrophil count >=1·5 Ã? 10â?¹ cells per L, platelet count >=100 Ã? 10â?¹ platelets per L, and haemoglobin >=9 g/dL [may have been transfused]), liver (defined as a total bilirubin concentration of <=1·5 Ã? the upper limit of normal [ULN] range and aspartate aminotransferase and alanine aminotransferase concentrations of <=2.5 x Ã? ULN; and renal (defined as an estimated creatinine clearance > 50 ml/min according to the Cockcroft-Gault formula)functions at the time of study inclusion.
- •7)Not known to be pregnant.
排除标准
- •Exclusion Criteria at the time of Registration
- •1)Patients with non-epithelial ovarian cancers.
- •2)Patients with early stage epithelial ovarian cancers at the time of their initial diagnosis defined as radiological stage 1 or 2, unless accompanied by massive ascites requiring neoadjuvant chemotherapy.
- •3)Patient with advanced epithelial ovarian cancer who undergo upfront debulking surgery as their initial treatment.
- •4)Current evidence of being pregnant at the time of Registration.
- •5)History of any previous malignancies within preceding 5 years with the exception of basal cell or squamous cell skin cancer or cervical pre-invasive neoplasia.
- •Exclusion criteria at the time of obtaining informed consent after NACT up to the time of intra-operative randomization:
- •1)Patients with advanced epithelial ovarian cancer, FT or primary peritoneal cancer who do not achieve optimal interval debulking surgery (the maximum size of any residual tumor of >5 mm).
- •2)Patients with any contraindication to HIPEC/NIPEC
- •3)Patients who are not suitable for subsequent adjuvant chemotherapy after surgery.
- •4)Other severe acute or chronic medical conditions including cardiac, pulmonary, gastrointestinal, neurological or other disorders; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigators, would make the patient inappropriate for entry into this study.
- •5)Patients who are not considered reliable for follow-up.
研究者
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