Merkel Positron Emission Tomography (PET) Protocol

NCT01013779 | Completed Phase 2 DMC

• 2 other identifiers: TROG 09.03ACTRN12610000480088
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 13

Brief Summary

A Phase II Study designed to evaluate the efficacy of Chemo-Radiotherapy in achieving loco-regional control in patients with Merkel Cell Carcinoma (MCC) of the skin. Patients will undergo PET scans to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment.

Conditions

Merkel Cell Carcinoma

Keywords

Merkel Cell Cancer; PET scanning

Outcome Measures

Primary Outcomes (2)

• Time to loco-regional failure curve

  Minimum of 18 months follow up

• Incidence of grade 3 and 4 toxicity and incidence of febrile neutropenia

  Duration of Radiotherapy treatment

Secondary Outcomes (4)

• Overall survival and time to distant failure curves

  3 year acturarial curves

• Proportion of patients for which PET can influence management.

  12 weeks post Radiotherapy

• Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of PET.

  12 weeks post Radiotherapy

• Post-treatment PET complete response rate for patients with unresected disease

  12 weeks post Radiotherapy

Study Arms (1)

Arm A

EXPERIMENTAL

Conventional radical radiotherapy in this trial means that those patients with microscopic disease receive a dose of 50Gy using daily incremental fractions of 2Gy over 25 fractions and those with macroscopic disease receive 54Gy in 27 fractions.

Drug: Carboplatin; Drug: Etoposide; Radiation: Radiotherapy

Interventions

Carboplatin DRUG

During radiotherapy: Carboplatin (AUC2) commences on day 1 of radiation and is repeated at weekly intervals on days 8, 15, 22 and 29 (of radiation). After radiotherapy: 3 weeks after completing radiotherapy, 3 cycles of 3 weekly carboplatin (AUC4.5) intravenously on day 1.

Arm A

Etoposide DRUG

After Radiotherapy: 3 weeks after completing the radiation therapy, 3 cycles of 3 weekly etoposide (80mg/M2/day) intravenously days 1-3

Arm A

Radiotherapy RADIATION

Microscopic Disease: 50Gy delivered in 2Gy doses over 25 fractions Macroscopic Disease: 54Gy delivered in 2Gy doses over 27 fractions

Also known as: RT, Radiation Therapy

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be registered on the trial only if they meet all of the following criteria:
• Age 18 years or older
• Written informed consent to participate in the study
• Able to undergo 18-FDG PET scan (no uncontrolled diabetes mellitus or severe claustrophobia).
• Available for follow-up.
• Using adequate contraception if capable of child bearing
• Any Merkel Cell carcinoma confined to the primary and/or nodal sites
• ECOG 0-2.
• Full Blood Count (FBC) should be satisfactory ( Haemoglobin \> or equal to 10g/dl, neutrophils \> or equal to 2.0 x 109 /l and platelets \> or equal to 100 x 109 /l) and renal function (GFR \> or equal to 50 ml/min) and hepatic function ( ALT \< 5 X upper limit normal, bilirubin \< 1.5 X upper limit normal)
• Patients must be able to tolerate protocol treatment

You may not qualify if:

• Previous chemotherapy in the past 5 years or prior radiotherapy to the area of concern
• Unable to comply with treatment protocol eg dementia
• Other malignancy in the past 5 years other than non-melanoma skin cancer.
• Women who are pregnant or lactating.
• Clinical evidence of metastatic disease.
• Immunosuppression from long term steroid use or immunosuppressive drugs.
• Any serious illness or medical condition that precludes the safe administration of the chemotherapy including:
• Active infection
• Uncontrolled or unstable cardiac disease including unstable angina, myocardial infarction within the last 3 months, and recurrent ventricular arrhythmias
• Patients may proceed to protocol treatment if they meet the following criteria:
• High risk disease with no evidence of distant spread: Biopsy proven MCC with a primary that is \> 2cm (T2N0M0= Stage II) and/or regional nodes (any T, N1M0= Stage III); OR Recurrent MCC not previously treated with radiation treatment; Dermal or in-transit metastasis with or without nodes; Occult primary with involved nodes
• Patients who have no metastases on CT or PET scan OR If CT is suggestive of metastases, they must be PET negative

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead

Study Sites (13)

Campbelltown

Campbelltown, New South Wales, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, Australia

Location

Royal Prince Alfred

Sydney, New South Wales, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Radiation Oncology Services - Mater Centre

Brisbane, Queensland, 4101, Australia

Location

Princess Alexandra Hospital Radiation Oncology

Brisbane, Queensland, Australia

Location

Royal Brisbane Hospital

Herston, Queensland, 4029, Australia

Location

Oncology Research Australia

Toowoomba, Queensland, 4350, Australia

Location

Genesis Cancer Care (previously Premion)

Tugun, Queensland, 4224, Australia

Location

Geelong Hospital

Geelong, Victoria, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Sir Charles Gairdner

Nedlands, Western Australia, 6009, Australia

Location

Related Links

• please visit this website for further trial specific information

MeSH Terms

Conditions

Carcinoma, Merkel Cell

Interventions

Carboplatin; Etoposide; Radiotherapy

Condition Hierarchy (Ancestors)

Polyomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• Michael Poulsen

  Trans Tasman Radiation Oncology Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 16, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

AU (13)