Beschreibung:

S1011 Pre-Randomization Off-Study Form (#52060) Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing Surgery for Invasive Bladder Cancer NCT01224665 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9399F2B7-7E68-06C0-E040-BB89AD436952

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=9399F2B7-7E68-06C0-E040-BB89AD436952

Stichworte:

Klinische Studie [Dokumenttyp]

Tumoren

Pre-Study Form

Harnblasentumoren

Versionen (3) ▾

26.08.12
08.01.15
24.03.15

Hochgeladen am:

24. März 2015

DOI:

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Lizenz:

Creative Commons BY-NC 3.0 Legacy

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Bladder Cancer NCT01224665

Details

Instructions: For registration step 1, submit this form within 2 weeks after going off study, if patient is off study without randomization to extended vs. standard LND. List treatments that the patient received. Systemic Therapy: List regimens, start and end dates. For multidrug regimens, do not list individual drugs separately; end date would be the date all drugs in the regimen were discontinued. Surgery: List type of surgery, and in the "end date" column, the date of surgery. Radiation: List sites, start and end dates (inclusive of boosts and implants)

StudyEvent: S1011 Pre-Randomization Off-Study Form (#52060)
1. Instructions: For registration step 1, submit this form within 2 weeks after going off study, if patient is off study without randomization to extended vs. standard LND. List treatments that the patient received. Systemic Therapy: List regimens, start and end dates. For multidrug regimens, do not list individual drugs separately; end date would be the date all drugs in the regimen were discontinued. Surgery: List type of surgery, and in the "end date" column, the date of surgery. Radiation: List sites, start and end dates (inclusive of boosts and implants)

Header

SWOG Patient ID

SWOG Study No.

Registration Step

Patient Initials (L, F M)

Institution/Affiliate

Physician

Participating Group Name

Participating Group Study No.

Participating Group Patient ID

Comments

Treatment Information

Did the patient receive any treatment (on this registration step)

Yes

Treatment Start Date (MM DD YYYY)

Treatment End Date (MM DD YYYY)

Regimen or Procedure or Site(s)

Off Treatment Reason

Off Study Reason (select one)

Ineligible For Randomization To Extended Vs. Standard Lnd Due To Extent Of Disease At The Time Of Surgery (1)

Adverse Event/side Effects/complications (2)

Patient Withdrawal/refusal (3)

Disease Progression (4)

Death On Study (5)

Other (6)

Adverse event/side effects/complications specify

Patient withdrawal/refusal, specify

Sites

Other specify

Off Study Date (MM DD YYYY Date of progression, death or decision to discontinue)

Additional Treatment

Will patient receive further treatment?

No (No)

Yes (Yes)

Unknown (Unknown)

Yes, specify

Vital Status

Date of Last Contact or Death (MM DD YYYY)

Vital Status

Alive (Alive)

Dead (Dead)

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