Clinical Trials Logo
  1. Home
  2. Adenocarcinoma
  3. NCT05581121

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer — PAROLA  

Adenocarcinoma Clinical Trial

Official title:
PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

Clinical Trial Summary

This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France. In this trial, patients will be assigned in one of the two following treatments arms: - Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations. - Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Each patient will be followed up for 5 years. A cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET/CT only followed by chemo-radiation. This study also has ancillary objectives: - Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche. - Radiomics: To study the contribution of radiomics and FDG-PET/CT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome. - Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05581121
Study type Interventional
Source Institut Claudius Regaud
Contact
Status Recruiting
Phase Phase 3
Start date December 20, 2023
Completion date December 2033
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT02292641 - Beyond TME Origins N/A
Withdrawn NCT05325164 - Methadone for 'Adenocarcinopathic' Pain Treatment Phase 3
Completed NCT02926768 - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors Phase 1
Recruiting NCT02125240 - Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma Phase 3
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT02454647 - Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients N/A
Completed NCT01579721 - Prospective Randomized Study of SILS Versus CLS for Rectal Cancer Phase 4
Completed NCT01206530 - FOLFOX/Bevacizumab/Hydroxychloroquine (HCQ) in Colorectal Cancer Phase 1/Phase 2
Withdrawn NCT01148082 - School Response to Families Who Have Children With Cancer N/A
Completed NCT00548548 - A Study of Bevacizumab in Combination With Capecitabine and Cisplatin as First-line Therapy in Patients With Advanced Gastric Cancer Phase 3
Completed NCT00377936 - EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Phase 2
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00183859 - Clinical and Pharmacokinetic Trial of Intra-Abdominal Irinotecan Phase 1
Recruiting NCT01930864 - Metformin Plus Irinotecan for Refractory Colorectal Cancer Phase 2
Completed NCT02498860 - Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung Phase 2
Terminated NCT01441128 - -02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04400474 - Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study Phase 2
Recruiting NCT02133196 - T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer Phase 2