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NELMAS: Comparing Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases

Sponsor
Imperial College London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05987176
Collaborator
(none)
90
Enrollment
2
Arms
62
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

An international multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best supportive care in patients after resection of neuroendocrine liver metastases.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An International Multi-centre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase II Study Comparing Adjuvant Treatment With 177Lu-DOTATATE (Lutathera®) to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2028
Anticipated Study Completion Date :
Dec 30, 2028

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard of Care

Control arm as per standard of care patients go on routine follow up post surgery.
Experimental: Treatment

Treatment with Lutathera post surgery.

Drug: Lutathera
Dosage: In total 14.8 GBq (400 mCi) 177Lu-DOTATATE administered in two equally divided doses. Each dose to be infused over 30 minutes. Duration of treatment: Two administrations of 177Lu-DOTATATE (each treatment 7.4 GBQ (200 mCi) at 8±1-week intervals, which can be extended to 16 weeks for resolving acute toxicity.

Outcome Measures

Primary Outcome Measures

  1. Disease Free Survival [5 years]

    To compare overall Disease-Free Survival (DFS) at 3 years after treatment with 177Lu-DOTATATE to best supportive care in patients with R0/R1 resected liver metastases of well differentiated (grade 1 or 2) GEP NET and no extrahepatic disease manifestation prior to randomization in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Written informed consent prior to any study related procedures

  2. Patients aged 18 years or older

  3. ECOG / WHO performance status 0 or 1

  4. Patients with well differentiated grade 1 or grade 2 (Ki67<20%) GEP NET confirmed by histological criteria with the primary localisation in stomach, pancreas, or gut

  5. Patients after R0 (complete macroscopic and microscopic resection) or R1 (complete macroscopic resection, microscopically positive resection margins) resection of neuroendocrine liver metastases confirmed by histological criteria

  6. Patients with a primary tumour already resected or in whom the primary tumour has been resected synchronously with liver metastases

  7. MRI scan prior to surgery (within 4 -6 weeks) confirming liver metastases and no extrahepatic disease (except resectable perihilar lymph node involvement and/or primary tumour, if still in place)

  8. Somatostatin receptor-based imaging (68Ga DOTA-TATE PET/CT prior to surgery (within 12 weeks) confirming liver metastases and no extrahepatic disease (except resectable perihilar lymph node involvement and/or primary tumour, if still in place)

Exclusion Criteria:

  1. Less than 4 weeks post-surgery, or any other medical treatment, including chemotherapy, radiotherapy, and intrahepatic therapy

  2. High grade neuroendocrine tumours (G3 NET, or neuroendocrine carcinoma [NEC])

  3. After R2 (tumour debulking, macroscopically incomplete resection) resection of neuroendocrine liver metastases

  4. Patients with non-resectable neuroendocrine liver metastases and/or non-resectable primary tumour and /or non-resectable perihilar lymph node metastases

  5. Pregnancy

  6. Subjects of childbearing potential (both male and female participants) not willing to use a combination of adequate contraceptive measures, e.g., oral contraceptives, IUD, barrier methods of contraception (condom or occlusive cap with spermicide)

  7. Patients who have received prior systemic and/or liver-directed treatment for their metastatic NET other than somatostatin analogues

  8. Hb concentration <5.0 mmol/L (<8.0 g/dL)

  9. WBC <2x109/L (2000/mm3)

  10. Platelets <75x109/L (75x103/mm3).

  11. Total bilirubin >3 x ULN.

  12. Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.

  13. Uncontrolled congestive heart failure (NYHA II, III, IV).

  14. Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.

  15. Prior external beam radiation therapy to more than 25% of the bone marrow.

  16. Kidney failure with serum creatinine >150 µmol/L (>1.7 mg/dL)

  17. Known hypersensitivity to somatostatin analogues

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT05987176
Other Study ID Numbers:
  • AF-ICL 01
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Neuroendocrine Tumors
Lutetium Lu 177 dotatate

Study Results

No Results Posted as of Aug 14, 2023