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Compares treatment options for Malignant Neoplasm of Anal Canal
Official title IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
ClinicalTrials.gov ID: NCT06630793
What this study is testing
- What it's testing
- The standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the IMRT technique along with chemotherapy. It is known that while IMRT has reduced treatment related side effects as compared to the older radiation techniques, reducing these side effects further still remains a major challenge.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age \> 18 and \< 80 years of age
- Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
- The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition)
- Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they...
- WHO or ECOG performance status 0-1
You likely can't join if
- Two or more synchronous primary cancers.
- When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in...
- Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- Poor reliability for follow-up and treatment completion.
See the full eligibility criteria
- Age \> 18 and \< 80 years of age
- Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
- The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition)
- Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they receive radical chemoradiation as standard treatment.
- WHO or ECOG performance status 0-1
- HIV testing is known and HPV (P16) testing done on tissue sample.
- With suitable blood test values for standard concurrent chemotherapy (Hb \> 10 mg/dL, ANC \> 1.5 cells/mm3, Platelets \> 100,000 cells/mm3, Creatinine \< 1.5 x ULN, Bilirubin \< 3 x ULN, ALT \< 3 x ULN) as deemed by a...
- The patient must be expected to tolerate the treatment and be compliant for follow up.
- No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc.
- Willing to consent to participate in the study.
- Two or more synchronous primary cancers.
- When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process.
- Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
- Poor reliability for follow-up and treatment completion.
The study team makes the final eligibility decision.
Where it's taking place
- Mumbai, Maharashtra, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mumbai, Maharashtra, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.