Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)
23. april 2019 opdateret af: Barts & The London NHS Trust
A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer
This will be the first study to assess the clinical feasibility of dose escalation with simultaneous integrated boost intensity-modulated radiotherapy for patients with locally advanced cervical cancer.
Following screening to confirm eligibility patients will commence a six week treatment period.
After this, patients will be followed up by visits to clinic every 3 months for a period of 24 months (2 years).
End of study is defined as 24 months after treatment.
Patients will be followed up for a minimum of 5 years (as per local policy) after treatment.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sheffield, Det Forenede Kongerige
- Sheffield Teaching Hospitals NHS Foundation Trust
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England
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London, England, Det Forenede Kongerige, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, Det Forenede Kongerige
- Hammersmith Hospital
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London, England, Det Forenede Kongerige
- Royal Marsden - London
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Histologically confirmed squamous cell carcinoma, adenocarcinoma or poorly differentiated carcinoma of the cervix
- FIGO stage IIB-IVA (any pelvic nodal status) and FIGO stage 1B2 and IIA with pelvic nodal involvement
- Measurable disease on MRI
- Age > 18 years (no upper limit)
- WHO performance status 0,1
- Adequate renal function with EDTA clearance> 55ml/min
- Adequate liver function, as defined by ALT or AST less than 2.5 x ULN, and bilirubin less than 1.25 x ULN
- Adequate bone marrow function, defined by WCC >3.0 x 109/litre, neutrophils > 1.5 x 109/litre and platelets > 100 x 109 /litre
- Able to understand and give written informed consent
Exclusion Criteria:
- Evidence of common iliac or para-aortic nodal involvement, or distant metastases
- Previous history of cancer except skin tumour
- Previous pelvic radiotherapy or surgery other than toparoscopic node disection
- Previous history of pelvic adhesions, inflammatory bowel disease, pelvic inflammatory disease or diabetes mellitus
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy if required. Acceptable contraception should be used such as barrier or hormonal methods.
- Females must not be pregnant or breastfeeding
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Dose escalation study
This is a dose escalation study of IMRT for women with locally advanced cervical cancer.
Three dose levels will be investigated, (although, the first dose level is considered to be the equivalent to a standard pelvic dose with parametrial boost).
Before moving to the next dose level it must be confirmed by the Chief Investigator that the Maximum Administrable Dose (MAD) has not been met in the previous dose level (see section 6.3).
If MAD is reached before dose level 3 the study will stop.
All patients enrolled on the study will undergo the same procedures at the same time points, regardless of the dose level they are being given (see section 5).
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Each patient will also receive chemotherapy with a drug called cisplatin, which is given intravenously through a drip in the arm once a week during their 6 week radiotherapy treatment.
Again this is standard treatment for any patient with cervix cancer.
Patients in this trial will receive radiotherapy to the pelvic area with additional chemotherapy (chemoradiotherapy).
This is the standard treatment for cervix cancer and will be almost identical to patients not taking part in this study.
As patients in the study will be treated with IMRT, the total radiation dose will be slightly higher but without increasing the dose to normal tissue in the pelvis.
This will mean the number of radiotherapy treatments that each patient receives in the study is between 27 and 30 compared with the usual 28.
Each patient will undergo 6 weeks of radiotherapy treatment and must attend the radiotherapy department hospital once daily (Monday to Friday) over 6 weeks.
Each treatment lasts for approximately 10 15 minutes.
This is exactly the same as standard practice if patients were not participating in the trial.
Andre navne:
Intracavitary brachytherapy Intracavitary brachytherapy will be given towards the end of external beam radiotherapy usually weeks five and six.
This is routine treatment and will be given according to local practice As is the convention patients will be reviewed weekly (more frequently if necessary) by their study doctor and will have weekly blood tests to measure full blood count and urea and electrolytes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Response rate assessed radiologically at 3 and 12 months
Tidsramme: 3 and 12 months
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3 and 12 months
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Local control of the disease at 2 years
Tidsramme: 2 years
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2 years
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Late toxicity at 2 years as defined by CTCAE v 3.0
Tidsramme: 2 years
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2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Melanie Powell, Barts & The London NHS Trust
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2010
Primær færdiggørelse (Faktiske)
1. juli 2018
Studieafslutning (Faktiske)
1. juli 2018
Datoer for studieregistrering
Først indsendt
28. oktober 2010
Først indsendt, der opfyldte QC-kriterier
28. oktober 2010
Først opslået (Skøn)
29. oktober 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6867
- ISRCTN76100993
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