Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000951550p
Ethics application status
Not yet submitted
Date submitted
18/06/2024
Date registered
6/08/2024
Date last updated
6/08/2024
Date data sharing statement initially provided
6/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Robotic vs Standard Keyhole Surgery for Early-Stage Lung Cancer: An Australian Randomised Controlled Trial (RAVAL)
Scientific title
Robotic vs Thoracoscopic Surgical Resection for Early-Stage Lung cancer: An Australian Randomised Controlled Trial (RAVAL)
Secondary ID [1] 312350 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial is related to NCT02617186 (Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early-Stage Lung Cancer: A Randomized Controlled Trial being conducted in Canada and France. The Australian version of this study is also examining a broader range of resections including bi-lobectomy, extended lobectomy, simple lobectomy or segmentectomy.

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 334124 0
Condition category
Condition code
Cancer 330796 330796 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial is evaluating Robotic surgery for resection of their early-stage lung cancer. Surgery will be performed by a qualified thoracic surgeon and the surgery will take up to 3 hours. This is a standard of care treatment of lung cancer currently via keyhole surgery where the surgeon operates the instruments robotically. The trial will be evaluating the short-term outcomes post-surgery (compared to VATS [Video-Assisted Thoracic Surgery] resection) such as length of surgery, complications, length of post operative hospitalisation, and will also evaluate quality of life post-surgery.
Intervention code [1] 328845 0
Treatment: Surgery
Comparator / control treatment
Trial is evaluating standard video-assisted thoracoscopic surgery for resection of their early-stage lung cancer. This is a standard of care treatment of lung cancer currently via keyhole surgery where the surgeon operates the instruments manually. The surgery typically takes up to 3 hours and will be performed by a specialist thoracic surgeon. The trial will be evaluating the short-term outcomes post-surgery (compared to robotic resection) such as length of surgery, complications, length of post operative hospitalisation, and will also evaluate quality of life post-surgery.
Control group
Active

Outcomes
Primary outcome [1] 338563 0
The trial is intended to determine the difference in participant-reported HRQOL outcomes between RTS-Lobectomy and VATS-Lobectomy at 12 weeks.
Timepoint [1] 338563 0
12 weeks post surgery.
Secondary outcome [1] 436748 0
Difference in quality of life between the treatment groups, as measured by which coincide with standard of care intervals of oncological surveillance.
Timepoint [1] 436748 0
Weeks 3 and 7 and 12; months 6, 12, 18, 24; and years 3, 4, and 5,
Secondary outcome [2] 436749 0
5-year survival rate
Timepoint [2] 436749 0
5 years post surgery.
Secondary outcome [3] 437677 0
Determination of higher quality pathological staging by improved lymphadenectomy.
Timepoint [3] 437677 0
Time of surgery.
Secondary outcome [4] 437679 0
Duration of surgery between RTS- Lobectomy vs VATS- Lobectomy
Timepoint [4] 437679 0
At completion of surgery
Secondary outcome [5] 437680 0
Amount of intraoperative blood loss with RTS-Lobectomy.
Timepoint [5] 437680 0
At completion of surgery.
Secondary outcome [6] 437683 0
Post-operative analgesia requirements between RTS-Lobectomy vs VATS-Lobectomy.
Timepoint [6] 437683 0
During the duration of stay in hospital and post discharge.
Secondary outcome [7] 437693 0
Length of chest tube drainage required
Timepoint [7] 437693 0
Hospital stay
Secondary outcome [8] 437694 0
Duration of hospital stay
Timepoint [8] 437694 0
Hospitalisation

Eligibility
Key inclusion criteria
• Age 18 years and above
• Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
• Candidates for minimally invasive pulmonary surgery, as determined by the operating surgeon.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Not a candidate for minimally invasive lobectomy

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by surgeon. To ensure balance within local data and international data, there will also be stratification by procedure extent, viz. lobectomy or segmentectomy. Participants will be randomised using a web-based Research Electronic Data Capture (REDCap).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Baseline characteristics of both treatment groups will be compared to ensure homogeneity in the patient population. Descriptive statistics will be reported by treatment group where categorical variables will be reported as counts (percentages) and continuous variables as mean (standard deviation) or as median (25th percentile, 75th percentile). All analyses of primary and secondary outcomes will be carried out based on the intention-to-treat principle. Unadjusted comparisons of continuous outcome measures will be carried out using an independent t-test or the Wilcoxon rank-sum test if the assumptions of the t-test were violated. Unadjusted comparisons of categorical outcome measures will be computed using the chi-squared test, or the Fisher’s exact test if any of the expected values in the contingency table is less than 5, or McNemar’s test. For adjusted analyses multivariable logistic regression analyses will be used for binary outcomes and multivariable linear regression for continuous outcomes. The results of comparisons between groups will be presented as mean differences for continuous outcomes and relative risks or odds ratios for binary outcomes, with corresponding 95% confidence intervals and associated p-values.
Survival will be compared using the Kaplan-Meier method and cox proportional hazard models. Survival curves will be compared using the Log-rank test. P-values will be reported to three decimal places with p-values less than 0.001 reported as p < 0.001. All international analyses will be performed using SAS. Table 2 provides a summary of the variables, measures and methods of analysis. Local analyses will be performed using the R statistical package.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
2/08/2027
Actual
Date of last data collection
Anticipated
2/08/2032
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26694 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 26695 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [3] 26696 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [4] 26697 0
Eastern Health - Box Hill
Recruitment postcode(s) [1] 42734 0
3065 - Fitzroy
Recruitment postcode(s) [2] 42735 0
3220 - Geelong
Recruitment postcode(s) [3] 42736 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 316758 0
Hospital
Name [1] 316758 0
St Vincent's Hospital Melbourne
Country [1] 316758 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318965 0
None
Name [1] 318965 0
Address [1] 318965 0
Country [1] 318965 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315526 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 315526 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 315526 0
Australia
Date submitted for ethics approval [1] 315526 0
26/08/2024
Approval date [1] 315526 0
Ethics approval number [1] 315526 0

Summary
Brief summary
This trial aims to determine if there is any difference in patient-reported health-related quality of life and other clinical outcomes for patients with early-stage non-small cell lung cancer (NSCLC) who will undergo surgical removal of their cancer by either robotic keyhole surgery (RTS) or video assisted keyhole surgery (VATS).

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with early-stage non-small cell lung cancer and you are able to undergo minimally invasive keyhole surgery for removal of your cancer. Your treating doctor will be able to review your lung images to determine whether this type of surgery is right for you.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to undergo surgery by one of two methods. Participants allocated to the first group will undergo robotic-assisted keyhole surgery, it is anticipated this procedure take up to 3 hours. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging.
Participants allocated to the second group will undergo video-assisted keyhole surgery, it is anticipated that this procedure will take up to 3 hours. During video-assisted keyhole surgery (VATS), the surgeon inserts a small camera into the lung that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed.

Both types of surgery are currently standard of care to successfully remove lung cancer. It is expected that participants in both groups will need to stay in hospital after their surgery to ensure there are no unexpected complications. If you choose to participate in this study, the research team will ask to review your medical records prior to the surgery and for up to 5 years after the surgery to follow your progress.

It is hoped this research will demonstrate any differences in patient outcomes following each type of surgery. If one surgical method is found to be more effective for removal of cancer and less painful for patients, the evidence gathered from this trial may be used to promote use of that surgical method for future cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134966 0
A/Prof Gavin Wright
Address 134966 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
Country 134966 0
Australia
Phone 134966 0
+613 94192477
Fax 134966 0
Email 134966 0
[email protected]
Contact person for public queries
Name 134967 0
Jane Mack
Address 134967 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
Country 134967 0
Australia
Phone 134967 0
+613 9231 1618
Fax 134967 0
Email 134967 0
[email protected]
Contact person for scientific queries
Name 134968 0
Gavin Wright
Address 134968 0
St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
Country 134968 0
Australia
Phone 134968 0
+613 94192477
Fax 134968 0
Email 134968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.