Evidence map›Paper›PMID 41152774›Full record

ArticleBMC cancer2025

PReCedeNT trial: Phase III randomized-controlled trial of Lutetium - 177 DOTATATE Peptide Receptor Radionuclide Therapy (PRRT) plus Chemotherapy versus PRRT alone in FDG-avid, Well-differentiated Gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Ameya D Puranik, Indraja D Dev, Sushil Yadav, Venkatesh Rangarajan, Archi Agrawal, Sandip Basu, Vikram A Chaudhari, Anant Ramaswamy, Vikas Ostwal, Manish S Bhandare and 12 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07185672 (PReCedeNT Trial), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07185672 phase3recruitingnot on this map

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

TypeinterventionalSponsorTata Memorial HospitalRan2019 to 2027Enrolled162ConditionsNeuroendocrine Neoplasia's (NENs), Neuroendocrine Tumor GEP Grade 1-3, Neuroendocrine Gastroenteropancreatic TumourArmsPeptide Receptor Radionuclide Therapy with Lu177 DOTATATE, Capecitabine plus temozolamide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Ameya D PuranikDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India. ameya2812@gmail.com.ORCID http://orcid.org/0000-0001-6125-992X
Indraja D DevDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Sushil YadavDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Venkatesh RangarajanDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Archi AgrawalDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Sandip BasuRadiation Medicine Center, Bhabha Atomic Research Center and Homi Bhabha National Institute, Mumbai, India.
Vikram A ChaudhariDepartment of Surgical Oncology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Anant RamaswamyDepartment of Medical Oncology, Tata Memorial Hospital, Mumbai and Homi Bhabha National Institute, Mumbai, India.
Vikas OstwalDepartment of Medical Oncology, Tata Memorial Hospital, Mumbai and Homi Bhabha National Institute, Mumbai, India.
Manish S BhandareDepartment of Surgical Oncology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Shailesh V ShrikhandeDepartment of Surgical Oncology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Rahul V ParghaneRadiation Medicine Center, Bhabha Atomic Research Center and Homi Bhabha National Institute, Mumbai, India.
Prabhat BhargavaDepartment of Medical Oncology, Tata Memorial Hospital, Mumbai and Homi Bhabha National Institute, Mumbai, India.
Munita M BalDepartment of Pathology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Subhash YadavDepartment of Pathology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Shraddha PatkarDepartment of Surgical Oncology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Mahesh GoelDepartment of Surgical Oncology, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai and Homi Bhabha National Institute, Mumbai, India.
Nilendu C PurandareDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Sneha ShahDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Sayak ChoudhuryDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Suchismita GhoshDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.
Manikandan VenkatachalamDepartment of Nuclear Medicine and Molecular Imaging, Tata Memorial Hospital, Mumbai and Advanced Center for Training, Research and Education in Cancer, Navi Mumbai, Homi Bhabha National Institute, Mumbai, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPeptide receptor radionuclide therapy (PRRT) with Lutetium-177 DOTATATE is the standard of care for well-differentiated metastatic or locally advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, tumor heterogeneity, particularly in FDG-avid tumors, can limit treatment effectiveness. The PReCedeNT trial aims to evaluate the efficacy of combining PRRT with capecitabine and temozolomide (CAPE-TEM) chemotherapy compared to PRRT alone in patients with FDG-avid, well-differentiated GEP-NETs.

methodsThis single-center, randomized, open-label, phase III trial will enroll patients with FDG-avid, well-differentiated GEP-NETs. Participants will be randomized in a 1:1 ratio to receive either PRRT alone or PRRT plus CAPE-TEM chemotherapy. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate, overall survival, toxicity, and quality of life parameters. The sample size of 162 patients was calculated based on the assumption that the addition of chemotherapy would improve PFS by an absolute value of 15% compared to the PRRT arm of the NETTER-1 trial. DISCUSSION: The combination of PRRT and chemotherapy may enhance treatment efficacy by targeting both somatostatin receptor-positive and FDG-avid tumor cells. By addressing the lack of prospective data on the efficacy of PRRT combined with chemotherapy in NETs, this trial aims to provide valuable insights into the benefits and risks of this combination. The results of this study have the potential to significantly impact the treatment strategies for patients with aggressive NETs, potentially improving the outcomes and quality of life of this patient population.

trial registrationThis trial is registered with the Clinical Trials Registry of India (CTRI/2019/07/027255) and ClinicalTrials.gov ID: NCT07185672.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsIntestinal NeoplasmsNeuroendocrine TumorsOctreotideOrganometallic CompoundsPancreatic NeoplasmsStomach NeoplasmsAdultAgedCapecitabineClinical Trials, Phase III as TopicFemaleFluorodeoxyglucose F18HumansLutetiumMaleCapecitabineFluorodeoxyglucose F18Lutetiumlutetium Lu 177 dotatateOctreotideOrganometallic CompoundsRadiopharmaceuticalsReceptors, PeptideTemozolomideCAPE-TEMFDG-avidGEP-NETsLu-177 DOTATATEPRRT

Identifiers

PMID41152774
PMCPMC12560366

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.