PReCedeNT Trial: Phase III Randomised Controlled Open Label Trial of Lutetium 177 PRRT Plus Chemotherapy Versus PRRT Aalone in FDG Avid Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Neuroendocrine tumours (NETs), better defined as neoplasms (NENs), are a heterogeneous group of neoplasms that range from well-differentiated tumours to more aggressive carcinomas. Peptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the established standard of care for patients with well-differentiated metastatic or locally advanced GEP-NETs. It has demonstrated a significant improvement in outcomes compared to Octreotide LAR, both as a first-line and second-line treatment approach, following the results of NETTER-1 and NETTER-2 trials, respectively. ENETS guidelines recommend the use of Ga-68 labeled DOTANOC/TOC/TATAE imaging only for WHO Grade 1 NET whereas FDG PET is the preferred modality for WHO Grade 3 NEN and NEC. For Grade 2 tumors (Mib index ranging from 3-20%), there are no strong recommendations for the addition of FDG PETCT in existing diagnostic algorithm. FDG PET positivity has been shown to be an independent predictor of shorter progression-free and overall survival in NET patients undergoing peptide receptor radionuclide therapy (PRRT). (8) Consequently, it is imperative to address FDG-avid tumors by integrating PRRT and chemotherapy. There are no strong recommendations for the grade wise management of GEP-NETs particularly grade 2 \& 3. Although recently published NETTER 2 trial substantiated the role of PRRT as a first line treatment for advanced grade GEP-NETs, still there is lack of evidence supporting the addition of chemotherapy in management of GEP-NETs. Given the absence of a prospective study to establish this treatment regimen, we designed a Phase 3 Randomized Controlled Trial to evaluate the combination of PRRT and CAPE-TEM-based chemotherapy in patients with FDG-positive metastatic well-differentiated NETs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female, age greater than 18 years

• Histopathological diagnosis of GEP-NET, necessarily satisfying all the the criteria below

• Well differentiated G2 (Ki67 : ≥3-20%) OR G3 (ki67- greater than 20-55%), OR

• Well-differentiated G1 (\<3%) with disease progression in last 6 months

• Positive Ga-68-DOTANOC PET/CT, Krennings score \>/=3

• Positive FDG PET imaging, grade 3 or 4 uptake

• Locally advanced/inoperable disease or metastatic disease

• Karnofsky performance-status score of at least 60 or ECOG performance status \</= 2

• Life expectancy greater than 6 months

Locations
Other Locations
India
Tata Memorial Hospital, Mumbai, India
RECRUITING
Mumbai
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
RECRUITING
Navi Mumbai
Contact Information
Primary
Sushil K Yadav, MSc
sushilyadav.crc@gmail.com
912224177000
Backup
Farkhanda K Khan, MSc
khanfarkhanda1998@gmail.com
912224177000
Time Frame
Start Date: 2019-08-07
Estimated Completion Date: 2027-08-07
Participants
Target number of participants: 162
Treatments
Active_comparator: Peptide Receptor Radionuclide Therapy with Lu177 DOTATATE
Patient in this arm will be treated only with 4 cycles of PRRT
Experimental: PRRT with Lu-177 DOTATATE PLUS Capecitabine-Temozolamide
Patient in this arm will be treated with combination of PRRT and Chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Hospital

This content was sourced from clinicaltrials.gov