PRRT alone versus PRRT plus chemotherapy for gastroenteropancreatic neuroendocrine tumors
Official title: 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
Run by Tata Memorial Hospital · NCT07185672 · Data updated 2026-11-12
This test sees if adding capecitabine–temozolomide chemotherapy to Lutetium‑177 DOTATATE PRRT helps adults with advanced gastroenteropancreatic neuroendocrine tumors live longer without the cancer getting worse.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 162 (estimated) |
| Sponsor | Tata Memorial Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Mumbai, Maharashtra and 1 other locations) |
| Status | Recruiting |
| Started | August 7, 2019 |
| Main results expected | August 7, 2027 |
| Study ends | August 7, 2027 |
| Registry record updated | September 22, 2025 |
| Trial ID | NCT07185672 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically confirmed gastroenteropancreatic neuroendocrine tumors—well‑differentiated G2 (Ki‑67 3–20%) or selected G3 (Ki‑67 up to 55%), or progressing G1—with Ga‑68 DOTANOC Krenning score ≥3, FDG PET positivity, adequate organ function, ECOG ≤2 (or Karnofsky ≥60), and life expectancy >6 months are ideal candidates.
✕Probably not a fit
Patients with poor renal function (creatinine >1.6 mg/dL or creatinine clearance <50 mL/min), severe cytopenias or other major lab abnormalities, poor performance status, life expectancy under six months, or without somatostatin receptor–positive disease are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 3 trial compares standard peptide receptor radionuclide therapy (Lu‑177 DOTATATE) alone to Lu‑177 DOTATATE combined with capecitabine‑temozolomide chemotherapy in adults with gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) who have somatostatin receptor–positive disease. Eligible tumors include well‑differentiated G1 (if recently progressed), G2 (Ki‑67 3–20%) and selected G3 (Ki‑67 up to 55%) cases, and require Ga‑68 DOTANOC PET Krenning score ≥3 and FDG PET positivity. Participants receive PRRT at study centers with scheduled imaging and lab monitoring to compare progression‑free survival, overall survival, and treatment‑related toxicity between the two arms. The trial is led by Tata Memorial Hospital with treatments delivered at Tata Memorial and ACTREC in the Mumbai/Navi Mumbai region of India.
Why it matters
Potential benefit: If successful, adding capecitabine‑temozolomide to Lu‑177 PRRT could extend progression‑free survival and increase tumor response rates for patients with higher‑grade or FDG‑positive GEP‑NETs.
How similar studies have gone: Previous randomized trials (NETTER‑1 and NETTER‑2) established the benefit of Lu‑177 PRRT versus somatostatin analogs, while adding capecitabine–temozolomide to PRRT has shown encouraging results in smaller or retrospective series but has not been confirmed in a phase 3 setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Serum creatinine level of more than 1.6 mg/dl or a creatinine clearance of less than 50 ml/min * Hemoglobin level of less than 8.0 g per deciliter * Red blood cell count noty less than 300,000/cubic millimeter White cell count of less than 2000 per cubic millimeter * Platelet count of less than 75,000 per cubic millimetre * Total bilirubin level of more than 3 times the upper limit of the normal range * Serum albumin level \< 3.0 g/dl * Treatment with more than 30 mg of octreotide LAR within 4 weeks before randomisation. * Peptide receptor radionuclide therapy at any time before randomisation * Pregnancy and Lactation * Patients with concurrent malignancies
Where it's running
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Tata Memorial Hospital, Mumbai, India
Mumbai, Maharashtra, India Recruiting -
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)
Navi Mumbai, Maharashtra, India Recruiting
Study contacts
- Principal investigator: Ameya Puranik, MD — Professor and Consultant
- Study coordinator: Sushil K Yadav, MSc
- Email: sushilyadav.crc@gmail.com
- Phone: 912224177000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.