ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000339954

Ethics application status

Approved

Date submitted

24/03/2011

Date registered

31/03/2011

Date last updated

11/05/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

Prospective Randomised Trial Of Extended Chemotherapy During The “Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer

Scientific title

Prospective Randomised Trial Of Extended Chemotherapy During The “Wait Period” Following Pre-Operative Neoadjuvant Chemoradiotherapy For Rectal Cancer

Secondary ID [1]

NONE

Universal Trial Number (UTN)

Trial acronym

WAIT study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

rectal cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will be a prospective randomised controlled trial comparing standard preoperative chemoradiotherapy followed by a wait period without chemotherapy (herein after called standard chemoradiotherapy (SCRT)) with standard chemoradiotherapy followed by a wait period with chemotherapy (hereinafter called extended chemoradiotherapy (XCRT)
Chemotherapy will be fluropyrimidine based using a standard regimen of infusional 5FU continuous throughout radiotherapy, at a dose of 225 mg/m2/day. A Picc line will be inserted prior to treatment and the infusional 5FU will be given through a Baxter infuser pump, in an ambulatory fashion, and will be changed once a week, for the duration of radiotherapy. Full blood count and MBA20 will be performed weekly during chemoradiotherapy. For patients on standard arm (SCRT), no further preoperative chemotherapy is planned. Patients on the investigational arm will receive further chemotherapy as bolus 5FU (450 mg/m2 with leucovorin at 50mg/m2, on each of 3 days, 3 weekly for 3 cycles (week 9, 12, 15). Fullblood count and MBA20 will be performed prior to each chemotherapy cycle. The wait period before surgery will be a standardised 10 weeks after completion of radiotherapy on both arms of the study

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

standard preoperative chemoradiotherapy followed by a wait period without chemotherapy

Control group

Active

Outcomes

Primary outcome [1]

The primary outcomes of this study are complete clinical and complete pathological response at the time of surgical management of rectal carcinoma. These are very simply determined as outlined above. The investigators believe this study can be completed very readily within a realistic time frame. Based on the expected response rates for SCRT (25%) and the recently published data on XCRT (65%) and assuming an alpha of 0.05 and a 90% power, a total of 50 patients (25 in each group) would be required.

Timepoint [1]

At the time of surgical management of rectal carcinoma

Secondary outcome [1]

nil

Timepoint [1]

nil

Eligibility

Key inclusion criteria

1.Histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms. from the anal verge on rigid sigmoidoscopy)
2.Non-metastatic (M0) disease as evidenced by CT chest and abdomen
3. Patients who following MDT discussion, are deemed to require long course preoperative chemoradiotherapy as appropriate neo-adjuvant therapy for their rectal cancer prior to surgical management (clinical stage T3/4 or any node positive disease). The nature of surgical management will be at the discretion of the surgeon responsible for their care.
4.WHO/ECOG Performance status <= 2
5.Adequate bone marrow, hepatic, and renal fuction Haemoglobin greater than or equal to10.0 g/dL (transfusions allowed to achieve or maintain levels) absolute neutrophil count greater than or equal to 1.5 x 10 9/L
platelet count greater than or equal to 100 x 10 9/L
ALAT greater than or equal to10 2.5 x ULN
ASAT greater than or equal to10 2.5 x ULN
Alkaline phosphatase greater than or equal to10 2.5 x ULN
Total bilirubin greater than or equal to10 1.5 x ULN
Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
6.Presence of adequate contraception in fertile patients

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Age – less than 18 or greater than 80 years
2. Inability to provide informed consent
3. Significant co-morbidities precluding the use of preoperative chemoradiotherapy, including the presence of clinically significant (i.e. active) cardiac disease
4. Known dihydropyrimidine dehydrogenase deficiency
5. Pregnant or breast feeding women

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

North Tce Adelaide
SA 5000

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Dept of Health

Address [1]

North Tce
Adelaide, SA 5000

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital

Ethics committee address [1]

North Tce 
Adelaide SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/02/2011

Ethics approval number [1]

100731

Summary

Brief summary

This study looks at whether receiving extra chemotherapy during a waiting period between radiotherapy and surgery can assist in shrinking a patient’s tumour even more when compared to just the waiting period alone and without any additional treatment. 

Who is it for? 
You are eligible for this study if you are 18 years and over, have a histologically proven adenocarcinoma, distal rectum (defined as being less than 12 cms from the anal verge on rigid sigmoidoscopy), and have non-metastatic (M0) disease. You may also be eligible if your health care professional recommends that you undergo long course preoperative chemoradiotherapy prior to surgery. More details on the eligibility criteria for this study can be found in the Inclusion Criteria field of this form. 

Trial Details
Normally between radiotherapy and surgery there is a 6 week wait period to see if the tumour shrinks. Recent studies have suggested it may be beneficial to have chemotherapy in this period – although this experimental approach has only been tried in a small number of patients. The aim of this study is to see whether extra chemotherapy given in this wait period shrinks the tumour even more. The waiting period in this study will be 10 weeks. We will assess this at the time of surgery by clinical response (no tumour visible by eye) and by pathological response (no tumour visible under the microscope). We will also use the samples we take from the tumour to see whether we can identify any factors which might predict better outcomes for all patients with rectal cancer. If you choose to take part in this study, you will be randomised to either the standard preoperative chemoradiotherapy followed by a 10 week wait period without any additional chemotherapy (the SCRT group) OR the standard chemoradiotherapy followed by a 10 week wait period with additional chemotherapy (the XCRT group). Chemotherapy will be fluropyrimidine based using a standard regimen of infusional 5FU continuous throughout radiotherapy, at a dose of 225 mg/m2/day. A Picc line will be inserted prior to treatment and the infusional 5FU will be given through a Baxter infuser pump, in an ambulatory fashion, and will be changed once a week, for the duration of radiotherapy. A full blood count and MBA20 test will be performed weekly during chemoradiotherapy. For patients on the standard arm (the SCRT group), no further preoperative chemotherapy is planned. Patients on the investigational arm (XCRT group) will receive further chemotherapy as bolus 5FU (450 mg/m2 with leucovorin at 50mg/m2, on each of 3 days, 3 weekly for 3 cycles (week 9, 12, 15).

Trial website

Trial related presentations / publications

none

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Jacqueline Stephens

Address

c/- Disicpline of Surgery
The University of Adelaide
The Queen Elizabeth Hospital
28 Woodville Road, Woodville South SA 5011

Country

Australia

Phone

061 08 8222 8482

Fax

061 08 8222 6028

[email protected]

Contact person for scientific queries

Name

Dr James Young / Dr Sid Selva

Address

Royal Adelaide Hospital
North Tce
Adelaide SA 5000

Country

Australia

Phone

061 08 82224000

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		https://onlinelibrary.wiley.com/doi/full/10.1111/c... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prospective randomized trial of neoadjuvant chemotherapy during the 'wait period' following preoperative chemoradiotherapy for rectal cancer: results of the WAIT trial.	2017	https://dx.doi.org/10.1111/codi.13724
Embase	Total neoadjuvant treatment and PD-1/PD-L1 checkpoint inhibitor in locally advanced rectal cancer.	2023	https://dx.doi.org/10.3389/fimmu.2023.1149122

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically